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Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-524135EnglishN-0001November30HealthcareSTUDY ON THE EFFECT OF GLYCEROL, PROPYLENE GLYCOL AND POLYSORBATE 80 ON
THE LIPOPHILIC BEHAVIOUR OF TRANDOLAPRIL
English0409MbahEnglish C. JEnglish EnwerejiEnglish P.OEnglishThe present study examines the lipophilic behaviour of trandolapril by partitioning the drug in a
chloroform-water system at room temperature. The aqueous vehicles investigated are glycerolwater,
propylene glycol-water and polysorbate 80-water systems. The results show that both the
binary combinations and the surfactant solution decreased the lipophilicity of trandolapril. The
order of decrease is: polysorbate 80> propylene glycol> glycerol. The findings suggest that
none of the vehicles investigated, has the potential of enhancing the vehicle-skin partition
coefficient and therefore might not be considered as potential dermal enhancers for trandolapril.
EnglishTrandolapril, partition coefficient, spectrophotometry.INTRODUCTION
The desire to use transdermal routes for potent drugs or to avoid certain unsuitable characteristics of oral administered drugs has empowered formulation scientists to employ various formulation approaches with the view of enhancing transdermal drug absorptions. Some of such approaches involve the use of ethosomes, liposomes, microemulsions, nanoemulsions, solid-lipid nanoparticles and transferosomes1,2,3,4 . These nanotechnology-based solutions are lipid-based systems employed to improve drug solubility and bioavailability of poorly soluble compounds. The formulations could contain glycerol, propylene glycol and polysorbate 80 either as co-vehicles or dermal permeation enhancers. For example, propylene glycol has been reported to enhance the dermal permeability of diazepam and midazolam maleate5 , estradiol6 and naloxone7 . Trandolapril (2S,3aR,7As)-1-[(2S)-2-{[(1S)-1- (Ethoxycarbonyl)-3-phenylpropyl]amino}- 1-oxopropyl]octahydro-1H-indole-2- carboxylic acid is a potent nonsulphydryl angiotensin converting enzyme inhibitor. Clinically, it used in the treatment of patients with congestive heart failure, hypertension and myocardial infarction8,9 . Commercially, trandolapril exists only in pharmaceutical solid dosage forms (tablets or capsules), however, the potential of formulating it into transdermal pharmaceutical products exists, if appropriate vehicles (or co-vehicles) and chemical dermal enhancers could be selected. The purpose of this investigation therefore, was to examine the lipophilic behaviour of trandolapril in these vehicles (or co-vehicles) by partitioning the drug between them and chloroform. It is hoped that such information, could provide an insight into its potential dermal absorption. Previous studies10,11.12 have shown that linear correlation exists between permeability coefficient and partition coefficient. Another report13 has also shown dermal permeability coefficient to depend on the partition coefficient and molecular weight of chemical compounds. However, as literature survey has shown little or no study on the lipophilicity of trandolapril in the studied vehicles (or covehicles), in this paper, we report the partitioning of the drug between these vehicles (or co-vehicles) and chloroform
MATERIALS AND METHODS
Materials
Trandolapril (Abbot Laboratories, USA), glycerol, propylene glycol and polysorbate 80 were purchased from Sigma-Aldrich (USA). Chloroform was purchased from Fisher Scientific (USA).
Standard solution
Stock solution of trandolapril (100 g/ml) was prepared in methanol. Aliquots (10.0- 50.0 g/m) of the standard stock solution were pipetted into a 10 ml volumetric flask, diluted to volume with methanol.
Partition coefficient determination.
The partition coefficient of trandolapril was determined in a chloroform-water system. To 5 ml of saturated chloroform solution containing 1 mg of trandolapril, 10 ml of saturated aqueous solution of different concentrations of glycerol, propylene glycol and polysorbate 80 were added. The flasks were stoppered and agitated at room temperature for 2 h to achieve complete equilibration. The aqueous phase was analyzed by a spectrophotometric method for trandolapril content at a maximum wavelength of 210 nm and its concentration was calculated from a pre-constructed graph. The partition coefficient of trandolapril was calculated using the following equation14: P = (C1-Cw)Vw CwVo where, P = partition coefficient, C1 = total concentration of trandolapril, Cw = concentration of trandolapril in the aqueous phase, Vw = volume of the aqueous phase, Vo = volume of the organic phase.
RESULTS AND DISCUSSION
The regression analysis of the calibration graph of trandolapril gave correlation coefficient of 0.9997. The results of the partition coefficient and estimated permeability parameters are presented in Table 1. The results show that all the vehicles or (co-vehicles) decreased the partition coefficient of trandolapril. The decreasing effect was observed with increasing concentration of each vehicle (or co-vehicle). Polysorbate 80-water system was noted to show the highest decreasing effect on the partition coefficient of the drug. The difference between the effect of glycerol and propylene glycol on the partition coefficient of trandolapril could be attributed to decrease in the ability of water molecules to squeeze out the drug molecules from the aqueous environment, resulting in less drug molecules moving into the organic phase. This phenomenon is applicable more to propylene glycol-water system than glycerol-water system. Furthermore, differences in the dielectric constant of the binary systems could also have contributed to the observed difference in the partition coefficient. However, with polysorbate 80-water system, the decrease in the partition coefficient could be as a result of micellar complexation or entrapment of trandolapril in micelles. A plot of logarithm of the observed partition coefficient versus the concentration of vehicle (or co-vehicle) gave linear relationships with correlation coefficients of –0.9501, –0.9498 for glycerol-water and propylene-water systems respectively and – 0.9399 polysorbate 80-water system. The graphs are shown in figure1 for the binary systems and figure 2 for polysorbate 80- water system. As an earlier report15 has shown that permeability coefficient is a useful parameter in evaluating percutaneous absorption, the potential permeability coefficient of trandolapril through the skin was estimated using the observed partition coefficient. The estimation was done by the application of previously reported dermal permeability equation13: log kp (cm/h) = -2.7 + 0.71 log P – 0.0061 MW, where kp is the dermal permeability coefficient, P is the observed partition coefficient of trandolapril, MW is the molecular weight of trandolapril. The estimated permeability coefficients were used to calculate the potential fluxes at steady-state using the following equation16: kp = Jss/C, where Jss is the flux at steadystate, C is the concentration (μg / ml) of the test compound. A comparison of the kp values of trandolapril in glycerol-water; propylene glycol-water system and polysorbate 80-water systems at a concentration level of 5 % w/v, showed glycerol-water system (1.3527 10-4 cm/h) with factors of about 1.2 and 3.9 much greater than propylene glycol-water system (11.460 10-5 cm/h) and polysorbate 80-water system (3.5070 10-5
CONCLUSION
The investigation shows that the studied vehicles (or co-vehicles) decreased the partition coefficient of trandolapril. Polysorbate 80-water system was observed to produce the highest decrease in the lipophilicity (defined by the partition coefficient) of trandolapril. As permeability through the skin depends partly on the partition coefficient of the drug, the study suggests that none of the vehicles (or covehicles) could enhance the transdermal absorption of trandolapril through vehicle/skin partition coefficient mechanism.
Englishhttp://ijcrr.com/abstract.php?article_id=2168http://ijcrr.com/article_html.php?did=2168REFERENCES
1. Touitou E, Godin B, Dayan N, Weiss C, Piliponky A, Levi-Schaffer F. Intracellular delivery mediated by an ethosomal carrier. Biomaterials 2001; 22:3053-59.
2. Baboota S, Alazaki A, Kehl K, Ali J, Dixit N, Shakael F. Development and evaluation of a microemulsion formulation for transdermal delivery of terbenafine. PDA J. Pharm. Sci. Technol. 2007; 61: 276-85.
3. Shakael F, Baboota S, Ahuja A, Shafq S, Faisal S, Ali J. Enhanced transdermal delivery of aceclofenac using nanoemulsion technique. J Pharm Pharmacol 2007; 93: 31-7.
4. Shafiq S, Shakael F, Telegaankar S, Ahmad FJ, Khar RK, Ali M. Development and bioavailability assessment of ramipril nanoemulsion formulation. Eur J Pharm Biopharm. 2007; 66: 227-42.
5. Toniton E. Transdermal delivery of anxiolytics. In vitro skin permeation of midazolam maleate and diazepam. Int J Pharm 1986; 33: 37-43.
6. Mollsaard B, Hoelgaard A. Permeation of estradiol through the skin. Effect of vehicles. Int J Pharm 1983;15: 185-97.
7. Panchagnula R, Salve PS, Thomas NS, Jain AK, Ramarao P. Transdermal delivery of naloxone: effect of water, propylene glycol, ethanol and their binary combinations on permeation through rat skin. Int J Pharm 2001; 219:95-105.
8. Peters DC, Noble S, Plosker GL. Trandolapril: An update on its pharmacology and therapeutic use in cardiovascular disorders. Drugs 1998; 56: 871-893.
9. Pederson OD, Bagger H, Kober L, Pederson C. Trandolapril reduces the incidence atrial fibrillation after acute myocardial infarction in patients with left ventricular dysfunction. Circulation 1999; 100: 376-80.
10. Hatanaka T, Inuma M, Sugibayashi K, Marimoto Y. Prediction of skin permeability of drugs 1: Comparison with artificial membrane. Chem Pharm Bull 1990; 38:3452-59.
11. Bunge AL, Cleck RL. A new method for estimating dermal absorption from chemical exposure 2, Effect of molecular weight and octanol-water partitioning. Pharm Res 1995; 12:88- 95.
12. Wagner H, Kosita K, Lehr C, Shaefer U. Correlation between stratum corneum/water partition coefficient and the amounts of flufenamic acid penetrated into the stratum corneum. J. Pharm. Sci. 2002; 91: 1915-21.
13. Potts RV, Guy RH. Predicting skin permeability. Pharm Res 1992; 9: 663-669.
14. Johnansen M, Bundgaard H Prodrugs as drug delivery systems XII. Solubility, dissolution and partition behaviour of N-mannich bases and N-hydroxymethyl derivatives. Arch Pharm Chem Sci Edu 1980a; 8:141-45.
15. Korinth S, Schaller KH, Drexler H. Is permeability coefficient (Kp) a reliable tool in percutaneous absorption studies. Arch Toxicol 2005; 79:155-59.
16. Julreht K, Keith AP, James AW. Development of a transdermal delivery device for melatoin in vitro studies. Drug Dev Ind Pharm 1998; 21; 1377-87.
Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-524135EnglishN-0001November30HealthcareA COMPARATIVE STUDY OF THE EFFECTIVENESS OF EIGHT WEEK EQUAL DISTANCE WALKING AND
RUNNING IN REDUCING BODY FAT OF YOUNG MALE STUDENTS MEASURED BY SKIN FOLD THICKNESS
English1016B.Sankarmani English I. Mohammed Ameer HussainEnglishObjectives: To know about the effectiveness of walking and running in reduction of body fat
mass, to know about the better method in reduction of body fat mass and to improve the fitness
of the general people and sports person by reducing body fat mass.
Subjects: A sample of 30 students between 15 to 17 years were selected from the population
by selection criteria and randomly allotted into two groups.
Methods: Two groups of 15 each assigned for walking and running with pre and post
evaluation of BMI and skin fold thickness and compared.
Results: The result shows that Body mass index (BMI) value reduced in walking (0.78) and
running (0.74)groups. Percentage of body fat reduced in walking (4.66%) and running groups
(2.94%). When comparing the effectiveness between walking and running group, higher
significant level seen with the walking group (0.001) than running group (0.01).
Conclusion: Walking and running reduces the body weight and both can be prescribed to the
healthier younger individuals to reduce body weight as fat mass.
EnglishBody fat mass, Skin fold thickness, Walking, RunningINTRODUCTION
“Practice Does Not Make Perfect, Perfect Practice Makes Perfect” Every sports person must be fit enough for an event selection. Fitness can be defined easily in a single word as a person's fitness, but it consists of cardio respiratory fitness, muscular strength, endurance, flexibility and range of motion, body composition and nutrition. A person is considered to be fit if only he fulfills all categories. Professional athletes and sports persons are adequately fit when comparing with the other persons, who exercise occasionally. Obesity is one of the common problems among these groups of amateur players. For example professional athlete's average body fat is less when comparing with the college runners. Obesity is a commonest problem among peoples, who are sedentary in their life style. Obesity is an independent risk factor for the development of coronary artery disease and is frequently a predecessor of type II diabetes and causes risk for weight related problems like hypertension hyper cholesterolemia, hyper insulinemia and hyper triglyceridemia all of which increases the risk for cardio vascular disease. Development of obesity in adolescence has been shown to correlate very strongly with obesity in adulthood and also the increased risk of disease. Lack of exercise and nutrition are significant factors in adolescence obesity. In active person any chronic imbalance on the energy input results in increased body mass (Energy input> Energy output). 1-2 Early intervention in adolescence obesity will prevent the adulthood obesity and its related disease. It is important to establish an ideal effective treatment in reducing adolescence obesity. Reduction of obesity will increase their self-esteem, psychological well being, and a positive feedback to be active and fit throughout their life. Alteration in fat mass can be achieved in two ways, 1. Modification of early nutrition and 2. Exercise Regular aerobic exercise like walking, jogging, running, cycling reduces body fat mass and preserves the lean body mass by burning fat for energy. But dieting reduces both the body fat mass and lean body mass. To maintain body composition, younger and healthier individuals can be involved in any one of activity but not advisable in case of old age and unhealthy individuals. Exercise prescription to maintain body composition should be a practicable, valuable and should consider according to the individual. Nowadays adolescent obesity emerges as a social problem and needs necessary action to be taken to prevent the social stigma. This should be properly controlled to avoid adulthood obesity and to reduce morbidity rates. 3 Walking and running are the most common activities followed by many people to reduce their body fat. Both walking and running has their own merits and demerits. Running requires less time to cover a distance than walking but cannot be followed by all for a long duration. Theories supports that fast walking requires more energy than running. Increased energy expenditure utilizes fat for energy and results in better weight reduction as fat mass and is useful for maintaining a good body composition.4-5 Walking, running are the common form of aerobic exercise followed by people to reduced their body weight by increased caloric expense by the exercise. Review of literature shows that walking at faster speeds requires higher energy expense than running. If walking is better than running, then the people can follow the walking to reduce their body weight, which is comparatively easier, and risk free than running. Sports persons also can use the better method to maintain their body weight in the off-season period along with their routine specific exercise. The understanding of the effectiveness of walking and running will guide the physiotherapists to select the better method for the needed person to reduce their body fat mass.
METHODOLOGY
Research Design Single Blinded Randomized study Setting of the study This study was conducted on eleventh standard boys of T V S Higher secondary School, Madurai. Sample A sample of 30 students were selected from the population by selection criteria and randomly allotted into two groups. Criteria for sample selection 1. Male students 2. Age group 15 to 17 years 3. Students without any medical problem
OUTCOME MEASURES 1. Body Mass Index
Body Mass Index (BMI) is calculated by using the following formula before and after intervention.
BMI = Weight (Kg) / (Height) 2 in meter
2. Percent of Body fat
Percent of body fat is calculated based on skin fold thickness and the equation for less than or equal 18 years males is,
Percent of Body fat = 0.735 (Σ 2 SKF triceps, sub scapular) + 1.6
Skin fold thickness (SKF) All skin folds should be taking on the dominant side. 2 to 3 measurements should be taken at each site averaging those within 1mm of one another. The site shall be Abdominal, Biceps, Triceps, Chest/Pectoral, Mid axillary, Subscapular, Suprailiac, Thigh and Medial calf. These two outcome measures were been used to collect data before and after eight weeks of intervention. Tester The tester of this study was a sports physical therapist working in a fitness center with 5 years of fitness testing experience. PROCEDURE
Both running and walking group were taught to do their workout in the following sequence. After each session the subjects were asked for their difficulty in running/walking. 1. Warm up (Stretching) - 5 to 10 Minutes 2. Walking/Running 3. Cool down (Stretching) - 5 to 10Minutes
1. Warm up
All 30 students were taught to do warm up daily before their work out. • Gentle movements of upper and lower limb (2-3 minutes) • Calf and hamstring stretching in stride standing. • Calf stretching on the edge of step. • Quadriceps stretching in one leg standing. • Stretching maintained for 10-20 seconds and repeated 3 times each. 2. Walking/Running A. Walking Randomly allotted 15 students in Group I were asked to walk briskly a distance as in the following manner. First Week: Distance – 1.5 Km, Frequency – 4 days/week, Speed – 8-9 Km / hour. Second to Eighth Week: Distance – 1.75 Km, Frequency – 4 days / week Speed – 8-9 Km / hour B. Running Randomly allotted 15 students in Group II were asked to run a given distance as in the following manner. First Week: Distance - 1.5 Km, Frequency - 4 days / week, Speed - 11-12 Km / hour Second to Eighth Week: Distance - 1.75 Km, Frequency - 4 days / week Speed - 11-12 Km / hour Cool Down • All 30 students were taught. • Stretching maintained for 10-20 seconds and repeated 3 times each.
RESULTS
The result shows that • Body mass index (BMI) value reduced in walking and running groups. Group I (Walking) – 0.78 Group II (Running) – 0.74 • Percentage of body fat reduced in walking and running groups. Group I (Walking) – 4.66% Group II (Running) – 2.94% • Both walking and running significantly reduced the body weight as fat mass. Group I (Walking) – 0.001 level of significance Group II (Running) – 0.01 level of significance When comparing the effectiveness between walking and running group, higher significant level seen with the walking group (0.001) than running group (0.01).
DISCUSSION
Percent of body fat measurement The selected subjects were sedentary and they had greater fat mass even they were in the normal body mass index (BMI) level. This supported by ACSM‘s resource manual that BMI is a poor predictor of percent of body fat. So in this study BMI is used as a tool to exclude the students who were very low in weight to their height. To predict percentage of body fat in children there are two formulas given by SLAUGHTER5 . One formula uses triceps and subscapular skin fold thickness and the other is triceps and medial calf. The subjects of this study goes to school by bicycle or walk, rarely by motorized vehicle and they were very minimally shown the medial calf skin fold thickness, but all the subjects showed the greater thickness in sub scapular site when comparing with Triceps and calf. To minimize the bias caused by skin fold thickness of medial calf, as it is already on regular aerobic exercise, the upper body sites of sub scapular and triceps were measured to calculate percent of body fat by Slaughter‘s formula. Intensity of training The first day of first week the students were asked to complete the distance of 1.5km. After the session the subject‘s pulse rate and respiratory rate were checked and asked about their difficulty feeling. They were able to complete the task with little difficult. Then they were advised to cover the same distance for the whole first week. At the end of last session of first week they said that their difficulty level is reduced. From second week onwards they were advised to complete 1.75km. This distance continued until the end of whole schedule for 8 weeks. Every week after completing the first session they were asked about their difficulty level orally and pulse rate and respiration was checked. The heart rate shown that they have achieved the 80 percent of their Target Heart Rate. BMI changes The results show the reduction of weight and BMI in both groups. This supported by CRAIG BW et al, MC ARDLE WE and TONER MM, WILMORE JH statements that endurance exercise reduces body weight6 . But there was no significant difference between the two groups this supported by POLLOCK ML et al7 . In this study, the subjects were free from diet control; even though they reduced their body weight this support by MILESIS CA et al and GETTMAN CR et al8 . Changes in percent of body fat The study results show the walking group reduced the percentage of body fat higher than the running group. This significant difference may be due to the increased caloric expense at the faster speed walk (> 8 km/hour) than walking at slower speed. The economy of walking at faster than 8km/hour was one half of that for running at similar speeds and it is more economic to jog/run rather than to walk at speeds greater than 8km/hour so the study results, the walking group significantly reduced their body fat mass than the running group. Clinical implication • Walking is one of the easier ways of doing aerobic exercise, which can be followed by anyone. • The results of this study showed that walking reduces greater fat mass when comparing with running. • So we can prescribe the walking to reduce the storage fat mass for all categories of people. • Risk of injury is high in running when comparing with the walking group.
CONCLUSION
Walking and running reduces the body weight and both can be prescribed to the healthier younger individuals to reduce body weight as fat mass. According to the individual‘s need and physique proper advice should be given to reduce the body weight. Walking at greater speeds reduces the body weight by greatly reducing the body storage fat in the young male students who were sedentary in their lifestyle. This walking type of exercise provides better start for endurance training with reduced risk of injury.
ACKNOWLEDGEMENT
Authors are greatful to Dr.Duraiarasan, Director, Alagar Fitness center, Madurai for working with us as blinded tester.
Englishhttp://ijcrr.com/abstract.php?article_id=2169http://ijcrr.com/article_html.php?did=2169REFERENCES
1. G R Hunter, R L Weinsier, P A Zuckerman and B E Darnell, Aerobic fitness, physiologic difficulty and physical activity in Black and White women ,International Journal of Obesity (2004) 28, 1111–1117.
2. B Gutin Diet vs. exercise for the prevention of pediatric obesity: the role of exercise Int J Obes 35: 29-32; advance online publication, July 20, 2010; 10.2010.140.
3. Fulton J, Dai S, Steffen L, Grunbaum J, Shah S, Labarthe D. Physical activity, energy intake, sedentary behavior, and adiposity in youth. Am J Prev Med 2009; 37: S40–S49.
4. Stevens S, Murray D, Baggett C, Murray D, Baggett C, Elder J et al. Objectively assessed associations between physical activity and body composition in middle-school girls. The Trial of Activity for Adolescent Girls.Amer J Epidemiol 2007; 166: 1298–1305.
5. Slaughter MH, Lohman TG, Boileau RA, etal, Skinfold equation for estimation of body fatness in children and youth. Human Biolo 1988; 60: 709- 723.
6. Katch FI, McArdle WD. Prediction of body density from simple anthropometric measurements in college age men and women. Human Biolo 1973: 45: 445-55.
7. Jackson AS, Pollock ML, Ward A. Generalized equations for predicting density of women. Med Sci Sports Exerc 1980: 12: 175-81.
8. Pollock ML, Gettman LR, Milesis CA, et al Effects of frequency and duration of training on attrition and incidence of injury. Med Sci Sports Exerc 1977; 9: 31-6.
Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-524135EnglishN-0001November30HealthcareA CLINICOPATHOLOGICAL STUDY OF ADENOMYOSIS AT HYSTERECTOMY
English1722Ramesh B.HEnglish Shashikala PEnglish ManjulaEnglish DoddikoppadEnglish Chandrasekhar H.REnglishBackground: Adenomyosis is a relatively frequent finding in the series of hysterectomies preformed for
menorrhagia and dysmenorrhoea. In spite of the fact that it causes distressing and often serious functional
disturbances requiring major operation for correction, many physicians, even gynaecologists have only a
passing acquaintance with this entity.
Aim: The present study sought to evaluate the clinopathological aspects of adenomyosis.
Materials and Methods:
The present study is a descriptive analysis of 896 hysterectomies received to
the department of pathology J.J.M Medical College, Davangere, for a period of 2 years. Adenomyosis
reported in 896 (49.04%) of 1827 uteri were included in the study irrespective of the preoperative
diagnosis. When adenomyosis was found it was recorded and graded as to depth of penetration and degree
of involvement.
Results: The prevalence of adenomyosis in 1827 hysterectomy specimen was 49.04% (896). Age of
patients ranged from 20 –75 years. The parity ranged from one to ten. Menorrhagia was the commonest
symptom. Leiomyoma was the common associated pathological lesion. In correlating adenomyosis with
clinical symptoms, menorrhagia and dysmenorrhoea increases in frequency as the depth of penetration
and degree of involvement of adenomyosis increases.
Conclusion: Adenomyosis is not a rare histopathological finding. Available evidence seems to generate
uncertainty regarding a casual relationship between adenomyosis and the symptoms attributed to it.
Majority of the patients with adenomyosis presented with various clinical features, which were clinically
attributed to associated diseases.
EnglishAdenomyosis, Parity, GradingINTRODUCTION
Adenomyosis was first described by Rokitansky in 18601 . In spite of long cognizance and many publications regarding adenomyosis there is still widespread disagreement as to its incidence, theories of origin, and associated pathology. Hyperestrinism has been frequently cited as the initiating factor in adenomyosis. This has never been substantiated, but the frequent association of endometrial hyperplasia and myomas with adenomyosis certainly tends to link adenomyosis in some way with uncompensated estrogen stimulation in many cases2 .
In reviewing the literature, adenomyosis is indeed an ?elusive? lesion. There are several reasons for this. First, the exact aetiology of adenomyosis is not known. Second, its precise incidence in surgical specimens is not known and variance between 8% - 40% is reported, depending on which study or text one reviews. Certain reviews reports a correct pre-operative diagnosis is less than 10% of the instances of proved adenomyosis3 . In spite of the fact that it causes distressing and often serious functional disturbances requiring major operation for correction, many physicians, even gynaecologists have only a passing acquaintance with this entity2 . In 60 to 80% of women with this condition also have other associated pelvic diseases such as leiomyomas, endometriosis and endometrial polyps. According to some authors, this frequent association tends to indicate hyperestrogenism as a common denominator4 . The present study sought to evaluate the clinopathological aspects of adenomyosis.
SUBJECTS AND METHODS
During the study period of 2years 1827hysterectomy specimens were received in the department of pathology J.J.M Medical College, Davangere. These specimens were fixed in 10% formalin for 24-48 hrs. Gross morphology of uterus with associated pathology was noted. Tissue bits from representative areas (3-6 blocks) were taken for histopathology examination. Multiple sections of 5 microns thickness stained with haematoxylin and eosin were studied. Adenomyosis reported in 896 uteri irrespective of the preoperative diagnosis were included in the study. The diagnostic criteria used in the identification was the presence endometrial glands and stroma at least one low power field below the basal layer of endometrium surrounded by myometrium. When adenomyosis was found it was recorded and graded as to depth of penetration and degree of involvement3 . Based on depth of penetration Grade I: one low power field below the basal endometrium, Grade II: penetration to mid myometrium and Grade III - penetration beyond mid myometrium. With respect to degree of Involvement were categorized as Slight: few (1-3) endometrial glands / low power field, Moderate: several (4- 9) endometrial glands / low power field and Marked: many (10 or more) endometrial glands/ low power field. These pathologic results were then reviewed and an attempt was made to correlate the pathologic findings with data, preoperative diagnosis and other clinical parameters.
RESULTS
Of the 1827 hysterectomy specimen received during the 2year period, adenomyosis was reported in 896 uteri (49.04%).
Patient profile
Age of patients ranged from 20 – 75 years with a mean age of 39.8years. Peak incidence was seen in fourth decade with 48.43% cases. Of these 892 patients were parous (99.55%) and only four were nulliparous (0.45%). The parity ranged from one to ten. Menorrhagia was the commonest symptom [Figure 1].
Histomorphology Of the 896 uterus studied, 475(53%) cases were normal in size, 391(43.64%) were bulky and only 30(3.36%) uteri were atrophic. On cut section, myometrium showed characteristic coarse trabeculated appearance which was diffuse in 677(75.55%) uteri and focal in 189(21.09%) uteri. However it was difficult to appreciate these features in 30 atrophic uteri. Small cyst like spaces with dark brown areas was observed in 150 adenomyotic uteri. 122(13.61%) uteri were associated with leiomyomas. Microscopically grade I adenomyosis was encountered in 528 uteri (58.93%), Grade II in 340 uteri (37.95%) and 28 uteri (3.12%) showed Grade III adenomyosis. Analysis of the degree of involvement of adenomyosis, slight or mild degree was commonest encountered in 580(64.73%) uteri followed by moderate involvement in 281 (31.36%) uteri and severe degree in 35(3.91%) uteri. Endometrial changes in Adenomyotic uterus: Proliferative phase was seen in 471 cases (52.56%) followed by secretary endometrium in 296 cases (33.04%) and cystic glandular hyperplasia in 72 cases (8.04%). Atrophic endometrium was found in 57 cases (6.36%). In 326 (36.38%) cases various associated pathological lesions were observed along with adenomyosis [Table 1].
DISCUSSION
The true incidence of adenomyosis is unknown. The frequency of adenomyosis reported in the literature ranges widely from 5 to 70%. The incidence of adenomyosis in the present study was 49.04% and preoperative clinical diagnosis of adenomyosis was done in only 31 cases (3.46%) similar to other studies1-3,5 .
Age/parity
In the present study the peak age incidence of adenomyosis was in fourth and fifth decades (73.88%) which is in accordance with other studies1-3,8. Adenomyosis typically affects multiparous patients1,4. In our study, most of the patients were multiparous (99.55%) as comparable to other studies2-4, 8,9. The overwhelming population of parous patients in various studies lends support to the concept that child bearing may play a role in the aetiology of adenomyosis2 .
Symptoms
The symptom association with adenomyosis is excessive uterine bleeding accompanied by worsening dysmenorrhoea. However adenomyosis may be entirely asymptomatic3,4. In the present study, incidence of menorrhagia in patients with adenomyosis was 50.55% similar to other studies3,7. Dysmenorrhoea from present study correlates with other studies1-3,6,7. As with other studies in the present study reported symptoms in cases of adenomyosis were heterogenous, nonspecific and probably related to the associated diseases4
Histomorphology
Diffuse enlarged uterus that is soft and tender on palpation is associated with adenomyosis3 . In the present series, adenomyotic uterine size was normal in 53% of cases, slightly enlarged or bulky in 43.64% of cases and was atrophic in 3.36% similar to other studies2 . This study shows that adenomyosis is not always associated with clinically demonstrable uterine enlargement, unless associated with leiomyomas similar to other studies2 . Grade I adenomyosis was commonest, found in 58.93% of uteri, followed by Grade II in 37.95% and Grade III in 3.12% in accordance with other studies3 . Present study showed mild adenomyosis in 64.73%, moderate degree in 31.36% and severe degree in 3.91% of uteri in contrast to other studies3 .
Association of Adenomyotic uteri with Clinical symptoms
Incidence of menorrhagia is directly proportional to the degree of involvement3 . With respect to degree of involvement the results in the present study was in accordance with other studies3 that, as the degree of involvement increases more frequent is the occurrence of menorrhagia. Present study shows dysmenorrhoea correlated with depth of penetration and degree of involvement Similar to other studies3, 4,11. which showed dysmenorrhoea increases in frequency as the depth of penetration and degree of involved increases, which substantiates Halls hypothesis3 .
Association of adenomyosis with other uterine pathology
In the present study, most of the uteri with adenomyosis showed proliferative phase (52.56%) followed by Secretory phase (33.04%), endometrial hyperplasia (8.04%) and atrophic in 6.36% of uteri which are in accordance with other studies2-4 . Present study shows additional pelvic pathology in 36.38% of adenomyotic uteri which is less in comparison to other studies2 . The incidence of leiomyoma in our study (13.61%) is similar to other studies7, 10,12 .
CONCLUSION
Adenomyosis is not a rare histopathological finding. Available evidence seems to generate uncertainty regarding a casual relationship between adenomyosis and the symptoms attributed to it. Majority of the patients in this study with adenomyosis presented with various clinical features, which were clinically attributed to associated diseases.
Englishhttp://ijcrr.com/abstract.php?article_id=2170http://ijcrr.com/article_html.php?did=21701. Azziz R. Adenomyosis: Current perspectives. Obstet Gynaecol Clinics of North America 1989; 16: 221-35.
2. Molitor J. Adenomyosis: A clinical and pathologic appraisal. Am J Obstet Gynaecol 1971; 110: 275-84.
3. Bird CC, Mcelin TW, Manola EP. The elusive adenomyosis of the uterus- revisited. Am J Obstet Gynaecol 1972; 112: 583-89.
4. Vercellini P, Ragni G, Trespidi L, Oldani S, Panazza ,S.et al: Adenomyosis: A Déjà vu ? Obstet and Gynaecol Survey 1993; 48: 789-94.
5. Vercellini P, Parazzini, Oldani S, Panazza S, et al. Adenomyosis at hysterectomy; a study on frequency distribution and patient characteristics. Human reproduction: 1995; 10:1160-2.
6. Kilkku P, Erkolla R, Gronroos M. Non specificity of symptoms related to adenomyosis: A prospective comparative survey. Acta Obstet. Gynaecol. Scand 1984; 63: 229-31.
7. McCausland A.M. Hysteroscopic myometrial biopsy: Its use in diagnosing adenomyosis and its clinical application. Am. J. Obstet. and Gynaecol 1992; 166:1619-28.
8. Wéry O, Thille A, Gaspard U, van den Brûle F. Adenomyosis: update on a frequent but difficult diagnosis. Gynaecol obstet Biol Reprod 2005; 34:633-48.
9. Bergholt T, Eriksen L, Berendt N, Jacobsen M, Hertz JB. Prevalence and risk factors of adenomyosis at hysterectomy. Hum. Reprod 2001;16: 2418-21
10. Yeniel O, Cirpan T, Ulukus M, Ozbal A, Gundem G, Ozsener S et al. Adenomyosis: prevalence, risk factors, symptoms and clinical findings. Clin Exp Obstet Gynecol. 2007; 34: 163-7.
11. Sammour A, Pirwany I, Usubutun A, Arseneau J, Tulandi T. Correlations between extent and spread of adenomyosis and clinical symptoms. Gynecol Obstet Invest. 2002; 54 :213-6.
12. Taran AF, Weaver AL, Coddington C, Stewart EA. Characteristics indicating adenomyosis coexisting with leiomyomas: a case–control study. Hum. Reprod 2010; 25: 1177-82.
Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-524135EnglishN-0001November30HealthcareEVALUATION OF EFFECT OF PRESSURE AND TEMPERATURE ON THE BIOAVAILABILITY OF MARKETED FORMULATION OF DICLOFENAC
English2330Mayee REnglish Rawat SEnglishThis study involves research to assess the pharmacokinetics of Diclofenac Sodium Marketed formulations
as well as the effect of pressure and temperature on its bioavailability by DermatoPharmacoKinetics
method. This drug is used for the treatment of Local pain. This was a single-dose-one arm, open label
pharmacokinetic study of marketed formulations of Diclofenac Sodium using 12 healthy Indian male
subjects. A marketed Diclofenac Sodium topical formulation was applied on the pre-marked forearms of
the subjects as per the dosing schedule. Subjects received treatment on one arm and same treatment on
another with the application of sufficient pressure in the first period and sufficient heat in the second period
of the study. The study was conducted following open label three way parallel design. A washout period
of two days was kept between the two periods of the study.
Skin Stratum Corneum samples were collected in sterile glass test tubes during each period. The samples
were collected pre-dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, and 6.0 hours post-dose application. The Stratum
Corneum samples were analysed for Diclofenac Sodium concentrations only. Pharmacokinetic parameters
of Diclofenac sodium were calculated as Cmax, tmax , AUC (0-t) and AUC (0-?) Diclofenac Sodium was
estimated in Stratum Corneum using a validated Spectroscopic method.
A total number of 12 subjects were enrolled in this study. The bioequivalence values of the test drug A
were Cmax of 23.767±2.398 μg/mL, tmax of 1.75 ±0.261 h, AUC0-t of 100.507± 10.455 h. μg/mL, AUC0-?
of 178.286± 22.859 h. μg/mL; after applying pressure, Cmax of 31.1± 2.742 μg/mL, tmax of 0.75 ±0.342 h,
AUC0-t of 103.555± 10.072 h. μg/mL, AUC0-? of 166.971± 47.627 h. μg/mL; and after using heat belt
Cmax of 28.084± 2.216 μg/mL, tmax of 1.75 ±0.261 h,
AUC0-t of 100.586±11.15 h. μg/mL, AUC0-? of 179.887± 21.553 h. μg/mL. This study demonstrated that
the bioavailability of the topical formulations increased with the help of pressure and temperature.
EnglishDermatoPharmacoKinetics, Stratum Corneum, Diclofenac, Skin stripping.INTRODUCTION
Bioavailability is typically defined as the rate and extent at which a drug reaches the general circulation from an administered dosage form. In case of topical formulations, the drug has to penetrate through the layers of skin to reach the local site of action which is a complex process only due to the rate limiting barrier of the Stratum Corneum[1] . The penetration of a drug through the skin is a complex process typically rate-limited by the stratum corneum (SC). This external layer of the skin is composed of terminally differentiated corneocytes embedded in a complex lipid matrix comprising primarily of ceramides, cholesterol, and free fatty acids. Delivery of drug by passive diffusion and the pharmacological effect elicited are dose-related: the better the drug permeates the skin, the greater the therapeutic effect. It follows, therefore, that formulation plays an important role in topical drug delivery as the composition of the vehicle will influence the partitioning and/or the diffusivity of the drug and hence the absolute amount delivered. The determination of the Bioequivalence of topical products involves the DermatoPharmacoKinetic (DPK) approach. The DPK approach includes measure of drug concentration in the skin, whether directly or indirectly related to the drug‘s therapeutic action, which can be determined continuously or intermittently for a period of time. This may include the measurement of either drug concentration in Stratum Corneum over time and/or drug concentration in serial biopsy samples. The measurement of the change in the Stratum Corneum drug concentration as a function of time is the objective of DPK approach and thus is a valid means of comparing a generic and innovator product for their ability to deliver drug to the deeper layers of the skin. DPK studies offer certain advantages such as: it is painless, the active drug substances (moieties) are protected from gastric enzymes, it avoids first pass effect, and it is simple to terminate if any adverse or undesired effect is observed. [2-4]
Various Techniques and Methods Practiced in DermatoPharmacoKinetics: - There are many in vitro and in vivo methods for pharmacokinetic assessment of the dermal products, of which the most important and easiest method is the in vivo tape stripping technique. Some of the other techniques are as mentioned below: Tape Stripping Technique:
Microdialysis[2,4]:
In Vitro Permeation Assessment[4,6];
Confocal Laser Scanning[4]:
Cadaver Skin Permeation[5]:
Vasoconstrictor Assay[5]:
Tape Stripping Technique: - The method consists of the standardized protocol of repeated applications and removal of adhesive tape on the skin surface, whereby consecutive layers of Stratum Corneum cells are sampled. Tape stripping is a standard measuring method for the investigation of the DermatoPharmacoKinetics of topically applied substances using adhesive films. These tape strips are successively applied and removed from the skin after application and penetration of topically applied substances; thus, the layers of the corneocytes and certain amount of topically applied substances are removed. The amount of the substances and the amount of Stratum Corneum removed with the single tape strip is determined for calculation of the penetration profile. The topically applied substances removed from the skin can be thus determined by various analytical methods like HPLC, Mass Spectroscopy and other spectroscopic measurements. [4,5] Diclofenac is an acetic acid non-steroidal antiinflammatory drug (NSAID) with analgesic and antipyretic properties. Diclofenac is used to treat pain, dysmenorrhea, ocular inflammation, osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, and actinic keratosis. Diclofenac has pharmacologic action similar to those of other prototypical NSAIDs. The exact mechanisms have not been clearly established, but many of the actions appear to be associated principally with the inhibition of prostaglandins synthesis. Diclofenac inhibits the synthesis of prostaglandins in body tissues by inhibiting cyclooxgenase; at least 2 isoenzymes, cyclooxygenase-2 (COX-1) and -2 (COX-2) (also referred to as prostaglandin G/H synthase- 1[PGHS-1] and [PGHS-2], respectively), which have been identified to catalyze the formation of prostaglandins in the arachidonic acid pathway. The pharmacodynamic effect is thought to reduce prostaglandin E2 (PGE2) synthesis.
SUBJECT AND METHOD
Study Subjects: Sufficient numbers of healthy Indian male human subjects was screened, out of those 09 male subjects were enrolled in the study and 03 male subjects were taken as standby. A total of 12 male subjects were applied with the study medication in the beginning of the study. The screening consent and study consent was taken respectively before drug application. Thereafter, subject‘s medical records were documented and physical examination was conducted. Inclusionexclusion criteria was also based on successful completion of a clinical health evaluation, which consisted of a personal interview; a complete physical examination (BP, pulse, weight, temperature, and respiratory rate); diagnostic testing that included a 12-lead electrocardiogram and chest radiograph; a laboratory testing that included a complete blood cell count, metabolic and hepatic tests (alanine amino transferase [reference range, 5-55 U/L], aspartate amino transferase [5-34 U/L]), urine analysis, blood chemistry for glucose (70-109 mg/dL), blood urea nitrogen (7-23 mg/dL), and creatinine (0.- 1.3 mg/dL), as well as serology tests for hepatitis (B and C), and HIV antibodies. Testing was performed by Central Pathology Laboratory, Shree Pathology Lab CIDCO, Aurangabad (MS). Subjects were excluded if laboratory values were significantly above or below the reference range and/or if all tests had not been performed. In addition, the laboratory data were reviewed by the investigators of the clinical unit prior to the enrollment of the subjects. Subjects were compensated for participation.
Study Design: This study was carried out as per the ICH (Step 5), ?Guidance for Good Clinical Practices (GCP)‘ and the principles of Declaration of Helsinki (Scotland, October 2000).The Independent Ethics Committee reviewed the protocol and the informed consent form for this study. A single-dose-one arm, open label, threeway parallel design was used. Subjects were admitted and housed in the clinical facility at least 2 hour before the application of the dose during each period of the study. Informed consent for the dosing / sampling procedure was obtained from each subject on admission to the clinical facility for the first study period. The marketed formulation of Diclofenac Sodium [Voveran Emulgel, Lic. No.: KTK/25/460/2001, Batch No.: 8Z099T, Mfg. Date: 12/2008 Exp. Date: 11/2011, Mfg. By: Novartis India Ltd., Bangalore] was applied on the forearm of the study subjects as per the dosing schedule. The dosing procedure was as mentioned below:
Both the forearms were washed with mild soap and copious amount of water and dried in air.
Both the forearms were marked for total of 08 application sites of 1 sq.cm area each.
5 mm length product was applied on all the sites so that the product completely and smoothly covers the site area.
The stratum corneum samples were collected from the sites on the desired pre decided time. The stratum corneum samples were collected for the first time as mentioned in the above procedure. After the pre decided time period the same procedure was repeated, but with simultaneous application of sufficient amount of pressure using pressure belt on all the sites. Then, the stratum corneum samples were collected from the sites after a desired pre decided time. Next, the above procedure was repeated with simultaneous application of a heat belt for a sufficient time period on all the sites where the study product was applied.
Stratum Corneum Sampling: Skin Stratum Corneum samples were collected in sterile glass test tubes during each period. The samples were collected pre-dose and at 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, and 6.0 hours post-dose application. The stratum corneum samples were analysed for Diclofenac Sodium concentrations only. For each subject the total number of blood draws were 02 (01 for screening and another during post study assessment); the total volume of blood withdrawn (10 ml for the pre-study evaluation and 10 ml for the post study) through the vein puncture did not exceed 20 ml.
Procedure Study samples were collected as follows. The pre-dose samples were collected within one hour prior to drug application. The post-dose samples were collected within 2 minutes of the scheduled time where the end time of collection to the nearest minute was recorded.
Before sampling, the drug remaining on the site was removed by mild force using three cotton swabs to ensure the complete removal of residual drug from the site.
The pre cut (1 sq. cm) adhesion tape was applied on the site and the mild force was applied to ensure the proper adhesion of the tape on the site area. The tape was removed and discarded.
Eight adhesion tape pieces were applied on the site area in the same manner and each tape was removed from the site before the next one was applied. The removal was done using the forceps and was done in one stroke to ensure the complete removal of stratum corneum.
All 8 samples tapes were collected in a single test tube which were then sealed and stored in the refrigerator at -200 c till analysed.
Analytical Method: A validated UV spectroscopic method was employed by using Chemito-Spectroscan UV 2600, Double Beam UV-Visible Spectrophotometer for the estimation of Diclofenac Sodium in human stratum corneum. This method involved the extraction of the Diclofenac Sodium form sample by using methanol and measuring the absorbance at 285nm. The concentration of Diclofenac Sodium in sample was determined from calibration curve. The standard stock solution of Diclofenac sodium was prepared by weighing 50mg of Diclofenac Sodium powder and shaking it with 60 ml of methanol in a 200-ml volumetric flask, which was then diluted with methanol. From the Diclofenac sodium stock solution 4ml was taken and diluted up to 100ml with methanol, to get the solution of 10µg/ml concentration. The test solution was prepared by taking 1, 2, 4, 6, 8, 10 ml from the standard stock solution in six different, labelled (1µg/ml, 2µg/ml, 4µg/ml, 6 µg/ml, 8 µg/ml) test tubes and making volume 27 International Journal of Current Research and Review www.ijcrr.com Vol. 03 issue 05 May 2011 up to 10ml by adding methanol. (Note: no need to add methanol in last µg/ml sample). Methanol was used as blank solution. Calibration Curve was prepared by using various dilutions (1 µg/ml -10µg/ml) as transferring required quantity of blank solution in to the cuvette and recording the absorbance, then taking the first test tube (1µg/ml), the required quantity of the test solution was transferred into the cuvette and the absorbance was measured recorded at 285 nm. The step 2 and 3 was repeated for remaining dilutions. Finally the graph of concentration versus absorbance Optical Density (OD) was
DISCUSSION
The results of our study showed that when we apply pressure on all the sites of drug application, the time required to achieve the Cmax gets reduced; also Cmax achieved was greater. On the other hand, when we use heat belt the Cmax was increased but the time required for this remained constant. No moderate or serious Adverse Events (AEs) were reported by the investigators. Potential recall bias of AEs in this study was not likely because only one dose of each formulation was administered during each treatment period, subjects were under medical surveillance in the clinical unit, and the duration of the washout period was only 2 days.
CONCLUSION
This study has demonstrated that for the topical formulations, the physical parameters like pressure or temperature acts as an aid not only to achieve higher tissue concentration but also to give the rapid onset of action.
DISCUSSION
The results of our study showed that when we apply pressure on all the sites of drug application, the time required to achieve the Cmax gets reduced; also Cmax achieved was greater. On the other hand, when we use heat belt the Cmax was increased but the time required for this remained constant. No moderate or serious Adverse Events (AEs) were reported by the investigators. Potential recall bias of AEs in this study was not likely because only one dose of each formulation was administered during each treatment period, subjects were under medical surveillance in the clinical unit, and the duration of the washout period was only 2 days
. CONCLUSION
This study has demonstrated that for the topical formulations, the physical parameters like pressure or temperature acts as an aid not only to achieve higher tissue concentration but also to give the rapid onset of action.
Englishhttp://ijcrr.com/abstract.php?article_id=2171http://ijcrr.com/article_html.php?did=21711. Center for Drug Evaluation and Research, Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products — General Considerations. US FDA. 2003.
2. Benfeld E, Steen H, Aage V., Torkil M and Shah VP. Bioequivalence of Topical Formulations In Humans: Evaluation By Dermal Microdialysis Sampling And The Dermatopharmacokinetic Method. Journal of Investigative Dermatology. 2007; 127:170- 178.
3. Shah VP, Glynn GL, Yacobi A. Bioequivalence of Topical Dermatological Dosage Forms –Method of Evaluation of Bioequivalence. Pharma. Research. 1998; 15(2):167-171.
4. Shah VP. Progress in Methodologies for Evaluating Bioequivalence Of Topical Formulations. Am. J. of Cl. Dermatology. 2001; 2(5):280.
5. Franz TJ, MD. Assessing The Validity Of Stratum Corneum Tape Stripping To Determine The Bioavailability / Bioequivalence Of Topical Drug Products. A letter to Roger Williams, FDA-CDER. 1999.
6. Herkenne C, Naik A, Kalia YN, Hadgraft J, Guy RH. Ibuprofen Transport into and through skin from topical formulations: In vitro-In vivo Comparison. The society of investigative dermatology. 2006.
Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-524135EnglishN-0001November30HealthcareCOMPARISON OF IMMEDIATE EFFECT OF MULLIGAN BENT LEG RAISE TECHNIQUE VS. PASSIVE STRETCHING ON HAMSTRING TIGHTNESS IN HEALTHY FEMALE VOLUNTEERS
English3135Cheraladhan E. SambandamEnglish Sejal N. SailorEnglish Tiruttani RameshEnglishBackground & Objective: Maintenance of flexibility is an essential component of any conditioning
program in developing joint mobility, improving athletic performance and preventing injuries. Good
flexibility also provides relaxation, ease muscle pain, helping quick recovery, reducing stress, keeping the
body feeling loose and agile. When soft tissue adaptively shortness overtimes muscle strength can also be
altered and length tension relationship of the muscle also altered. As the muscle shorter it no longer is
capable of introducing peak tension and develops tight weakness. Flexibility in hamstring muscle group is
necessary for the knee extension as well as many functional activities and in prevention of injury in which
the muscle group is elongated over hip and knee simultaneously. The study is aimed to compare the
effectiveness of Mulligan Bent Leg Raise technique and passive stretching on hamstring tightness.
Materials and Method: An experimental study was done to compare the Mulligan Bent Leg Raise
(MBLR) technique and passive stretching on hamstring muscle tightness. The study was conducted in a
physiotherapy college in Vadodara, India and ethical clearance was obtained from Institutional Review
Board. Sixty healthy female volunteers after signing informed consent form within the age of 20 - 30
years with tight hamstring muscles were randomly assigned into two groups. Group-1, Receiving
Mulligan Bent Leg Raise technique and Group-2, receiving passive stretching with knee extension.
Straight Leg Raise was measured with measure tape in centimeters from tip of the heel perpendicular to
the plinth before and immediately after intervention. Paired and independent t-test was used to analyze
data for significant improvement and homogeneity between groups.
Conclusion: This study concludes that there is significant improvement in Straight Leg Raise in both the
techniques but Mulligan Bent Leg Raise Technique is significantly more effective than passive stretching
in healthy females with Hamstring muscles tightness or limited Straight Leg Raise.
EnglishBACKGROUND AND OBJECTIVE Maintenance of flexibility is an essential component of any conditioning program in developing joint mobility, improving athletic performance and preventing injuries. Good flexibility also provides relaxation, ease muscle pain, helping quick recovery, reducing stress, keeping the body feeling loose and agile. When soft tissue adaptively shortness overtimes muscle strength can also be altered and length tension relationship of the muscle also altered. As the muscle COMPARISON OF IMMEDIATE EFFECT OF MULLIGAN BENT LEG RAISE TECHNIQUE VS. PASSIVE STRETCHING ON HAMSTRING TIGHTNESS IN HEALTHY FEMALE VOLUNTEERS Cheraladhan E. Sambandam1 , Sejal N. Sailor2 , Tiruttani Ramesh3 1Kashiba Jayashanker Pandya College of Physiotherapy, Sumandeep Vidyapeeth, Vadodara 2 Sri Swaminarayan Physiotherapy College, Surat E-mail of corresponding author: cheranmpt81@gmail.com 32 International Journal of Current Research and Review www.ijcrr.com Vol. 03 issue 05 May 2011 shorter it no longer is capable of introducing peak tension and develops tight weakness. Flexibility in hamstring muscle group is necessary for the knee extension as well as many functional activities and in prevention of injury in which the muscle group is elongated over hip and knee simultaneously.1 James and Karen et al have concluded that an increase in hamstring tightness may induce prolonged forefoot loading and through the windness mechanism be a factor that increases repetitive injury to the plantar fascia.2 Cooney KM., Sanders JO., Concha MC., Buczeh FL., have concluded that available knee extension, defined on the basis of clinical measures of first resistance to hamstring stretch, provides a biomechanical link between physical examination finding and dynamic limitation in terminal swing knee extension.3 Various researches4-9 have been made on different technique for improving hamstring tightness. Mulligan Bent Leg Raise technique being one of the developed technique to train stretch receptor of the muscle spindle to immediate accommodate a greater muscle length. The goal of this technique is to regain and to re-establish normal range of motion of hip and knee joint and mobility of soft tissues around nee joint. The study is aimed to assess the effectiveness of Mulligan Bent Leg Raise technique on hamstring tightness, to assess the effectiveness of passive stretching on hamstring tightness and to compare the effectiveness of Mulligan Bent Leg Raise technique and passive stretching on hamstring tightness.
MATERIALS AND METHOD
An experimental study was done to compare the Mulligan Bent Leg Raise (MBLR) technique and passive stretching on hamstring muscle tightness. The study was conducted in a physiotherapy college in Vadodara, India and ethical clearance was obtained from Institutional Review Board. Sixty healthy female volunteers after signing informed consent form within the age of 20 - 30 years with tight hamstring muscles i.e. subjects with decreased Straight Leg Raise (SLR) test (less than 70 cm) were randomly divided in to two groups thirty each, Group- 1: Receiving Mulligan Bent Leg Raise technique with 3 repetition of pain free five second isometric contraction of the hamstring muscles and Group-2: Receiving passive stretching with knee extension with 3 repetition of 30 second hold for hamstring muscles for both sides, first right side was completed and then the left side. SLR was measured with measure tape in centimeters from tip of the heel perpendicular to the plinth before and immediately after intervention.
Procedure
Mulligan Bent Leg Raise Technique Physical Therapist stands at the side of the subject while the subject is in supine. Firstly stretch the right side and then on the left side. Place subject‘s flexed knee over Physical Therapist‘s shoulder and now ask her to push away with her leg and then relax. At this point push her bent knee up as for as you can in the direction of her shoulder on the same side provided there is no pain. It is painful after the direction by taking her leg more medially or laterally. Sustain for thirty seconds and lower the leg to the bed with the bent knee over your shoulder. After being repeated 3 times you expect a marked improvement when you again to SLR. Place your one hand under her knee and clasp under her heel with other. You flex her hip as for as possible keeping her knee flexed. The heel would now be off the bed. The patient is now asked to push her leg down to the bed against your resistance and then relax. At the point you raise the leg gently as for as you can from the bed maintaining or increasing the knee flexion and introducing some hip-abduction at the same time. There must be no pain if painful after the directions of raised leg medially or laterally or even add some hip rotation. If still painful abandon the technique. As with the knee over your shoulder repeat 3 times and then reassess.10
Technique Used For Passive Stretching With the subject‘s knee fully extended support the patient‘s lower leg with your arm or shoulder. Stabilize the opposite extremity along the anterior aspect of thing with your other hand or a belt or with the assistance of other person. With the knee in maximum extension, flex the hip as for as possible. Alter the position. Kneel on the mat and place the subject‘s heel against your shoulder place both of your hands along the anterior aspects of the distal femur to keep the knee extended. The opposite extremity is stabilized in extension by a belt or lower and held in place by therapist‘s knee.1
RESULTS
Table-1 shows the Comparison of SLR value of Mulligan Bent Leg Raise Technique and passive stretching before and after intervention with paired t-test for both sides separately with its p value. In MBLR group for right side SLR value the mean ± SD before intervention is 63.70 ± 4.18 and after intervention is 79.65 ± 3.57, for left side before is 63.90 ± 3.75 and after is 78.70 ± 2.62 with p < 0.001 showing significant reduction in hamstring muscles tightness. In passive stretching group for right side SLR value the mean ± SD before intervention is 63.40±3.48 and after intervention is 72.75 ± 3.71, for left side before is 62.95 ± 3.57 and after is 72.05 ± 3.72 with p < 0.001 showing significant reduction in hamstring muscles tightness. Homogeneity of both groups before intervention was tested by using independent t-test, the p value for right side is equal to 0.807 and left side is 0.418 proves the same between groups. Inter group comparison of after intervention values are also done by using independent t-test which was showing pEnglishhttp://ijcrr.com/abstract.php?article_id=2172http://ijcrr.com/article_html.php?did=21721. Carolyn Kisner , Lynn Allen Colby : Therapeutic exercise : Foundation and Techniques : 1996; 144, 174 – 175.
2. Harty James, Soffe Karen, O‘toole Gary; Stephens Michael M:The Role Of hamstring tightness in plantar fasciitis. Foot and ankle international. ISSN 1071-1007, 2005, Vol. 26, No. 12. PP 1089-1092.
3. Cooney KM, Sanders JO, Concha MC, Buczek EL: Novel biomechanics demonstrate gait dysfunction due to hamstring tightness. Clin. Biomech. (Bristol, Avon) 2006 Jan: 21 (1) 59 – 66.
4. D. Hopper, S Deacon, S Das, A Jain, D Riddell. Dynamic soft tissue mobilization in increases hamstring flexibility in healthy male Subjects : Curtin University of Technology, shenton park, WA 6008, Australia 2005.
5. Feland JB Marin HN : Effect of Submaximal Contraction intensity in Contract-relax proprioceptive neuromuscular fascilitation stretching; Br. J Sports Med. 2004.
6. Halbertsma JP, Goeken LN, Stretching exercises: effect on passive extensibility and stiffness in short hamstrings of healthy subjects; Arch Phys Med Rehabil. 1994 Sep;75(9):976-81
7. Hall T., Anuar K, Darlow B, Ryder M, Smith T: The effect of Mulligan traction straight Leg Raise in Participants with short hamstrings; Annn, Acad, Med, Singapore 2003 Sep (32).
8. Spernoga SG, ULITL, Arnold BL, Gonsheder BM Duration of maintained hamstring Flexibility after a one time, modified hold-Relax Stretching 35 International Journal of Current Research and Review www.ijcrr.com Vol. 03 issue 05 May 2011 protocol. J Athl Train 2001 Mar. 36(1) 44-48.
9. Teys P. Bisset L, Vicenzino B, The initial effect of a Mulligan‘s mobilization with movement technique on range of movement and pressure pain threshould in pain-limited shoulder; Man. Ther, 2006 Oct; 25.
10. Brain R. Mulligan Manual Therapy: 2005: 70 – 71.
11. Hall T, Hardt S, Schafer A, Wallin L: Mulligan bent leg raise technique –a preliminary randomized trial of immediate effects after a single intervention; Man; Ther. 2006, May: 11(2) 130 – 5.
12. Halbertsma JP, Mulder I, Goeken LN, Eisma WH: Repeated Passive stretching : Acute effect on the passive muscle movement and extensibility of short hamstring Arch. Phys Med, Rehabil 1999 Apr. 80(4) 407 – 14.
13. Vicenzion B, Paungmali A, Teys PMulligan‘s mobilization with movement, positional faults and pain relief current concepts from a critical review of literature Man, Ther. 2006 Sep 5.
Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-524135EnglishN-0001November30HealthcarePATIENT COUNSELLING: A WAY TO ENHANCE PATIENT COMPLIANCE
English3647Stuti GuptaEnglish Ravindra Pal SinghEnglish Rajendra k. SongaraEnglish Sonia BislaEnglish Heema NaikEnglish Dolly JainEnglishEffective patient counseling makes the patient understand his/her illness, necessary lifestyle
modifications and pharmacotherapy in a better way and thus enhance patient compliance. The
pharmacist has immense responsibility in counseling the patients. The counseling pharmacist
should possess adequate knowledge and should be an effective communicator, making use of the
verbal and non-verbal communication skills.
Englishpatient counseling, pharmacist1. INTRODUCTION
The availability of and rational use of medicines are critical for a successful therapeutic outcome. Though rapid developments in science and technology have led to easy understanding of etiology and pathophysiological basis of various diseases and development of new molecules, many times clinicians fail to achieve the desired therapeutic goals. One of the major reasons for this can be the patient noncompliance or partial compliance towards the prescribed treatment (World Health Organization, 2003). Patient compliance is defined as the adherence of a patient towards the prescriber‘s instructions. It implies an understanding of how the medicine is to be used, as well as a positive behavior in which the patient is motivated sufficiently to use the prescribed treatment in the manner intended because of a perceived self-benefit and a positive outcome (e.g. enhanced quality of life and well being). Non- compliance can lead to various consequences including underuse, overuse, misuse, abuse etc (Hussar DA, 2000). The most common factors associated with noncompliance are the nature of the disease, multiple drug therapy, frequency of drug administration, duration of drug therapy, adverse events, cost of medications, administration technique, taste of medication etc (Ramesh, 1999). In the present days, the term ?concordance? is used more often in place of ?compliance?.
2. PATIENT COUNSELING [17] Patient counseling may be defined as providing medication information orally or in written form to the patients or their representative or providing proper directions PATIENT COUNSELLING: A WAY TO ENHANCE PATIENT COMPLIANCE Stuti Gupta1 , Ravindra Pal Singh2 , Rajendra k. Songara1 , Sonia Bisla1 , Heema Naik1 , Dolly Jain1 1 School of Pharmaceutical Sciences, Jaipur National University, Jaipur, rajasthan 2Gyan Vihar School of Pharmacy, Suresh Gyan Vihar University, Jaipur E-mail of corresponding author: stutipharmabird@gmail.com 37 International Journal of Current Research and Review www.ijcrr.com Vol. 03 issue 05 May 2011 of use, advice on side effects, storage, diet and life style modifications. It involves a one-to-one interaction between a pharmacist and a patient and/or a care giver. It is interactive in nature. The effective counseling should encompass all the parameters to make the patient/party understand his/her disease, medications and life style modification required (Beardsley , 1997); ASHP, 1997). In general, patient counseling has 3 main objectives: [18] (1) Assessing the patient‘s understanding of the therapy including proper use and adverse effects of the medication. (2) Improving patient adherence. (3) Motivating the patient to take an active role in health management. [19] Studies have shown that patient counseling can improve patient care in various ways [19]:
Reducing medication errors.
• Increasing patients understanding and management of their medical condition.
• Minimizing incidence of adverse drug reactions and drug-drug interactions.
• Improving patient outcomes and satisfaction with care. Although every pharmacist implements individualized techniques to counsel patients, various skills are vital to successful pharmacist-patient interaction during patient counseling sessions.
2.1 FEATURES OF EFFECTIVE PATIENT COUNSELING: [18] (1.) Establish Trust- Pharmacists are among the most accessible and trusted health care professionals. When initiating a patient counseling session, pharmacists should introduce themselves with a brief, friendly greeting to make patients feel comfortable enough to ask questions about their medication therapies and health conditions. Pharmacists who demonstrate a genuine interest in patient care are more likely to encourage dialogue. [20]
(2.) Communicate verbally- Pharmacists can encourage dialogue by asking questions. They should assess what the patient already knows about his or her chosen therapy and tailor the counseling to meet the needs of each individual patient. Ask patients what their physician has told them about the selected therapy and the condition for which they are being treated.
(3.)Communicate Nonverbally- In addition to verbal communication, it is essential for pharmacists to be aware of nonverbal communication, such as maintaining eye contact with the patient, to demonstrate interest in the information the patient is relaying. [21]Pharmacists also should be cognizant of other nonverbal clues, such as facial expressions and tone of voice, when interacting with patients.
(4.) Listen- When counseling patients about medication therapy, listening to the concerns, questions, and needs of the patient is essential. Listening skills can be categorized into 4 classes: passive listening, acknowledgment responses, encouragement, and active listening. [22] Passive listening occurs when the pharmacist enables the patient to communicate without interruption. An acknowledgment response such as nodding occurs during passive listening and alerts the patient that the pharmacist is indeed listening. Pharmacists also can use encouragement strategies through the use of words such as "yes" or "go on." Active listening involves 2- way interactions between the patient and the pharmacist and always should be implemented after passive listening. [22]
(5.) Ask Questions- When posing questions to the patient, pharmacists also should state the reason for asking certain questions, so as not to offend the patient. [23,24]Asking open-ended questions enables pharmacists to gather more information that may lead to other questions and/or provide valuable information to the pharmacist to further assess the patient.
(6.) Remain Clinically Objective- It is important for pharmacists not to allow personal belief‘s either ethical or religious‘ to affect their ability to counsel a patient effectively. Pharmacists should make every possible effort to be nonjudgmental and impartial, to focus on patient care, and to maintain a professional demeanor.
(7.) Show Empathy and EncouragementWhen a pharmacist displays empathy and encouragement, a patient may feel more comfortable discussing his or her medical condition and medication use, thus enabling the pharmacist to obtain pertinent information on the patient‘s needs and concerns. Emphasizing to patients the importance of adherence to medication regimens can promote positive therapeutic outcomes and motivate patients to take an active role in the management of their health. During counseling, pharmacists also should remind patients to call the pharmacy or their physician with any concerns about their medications.
(8.) Provide Privacy and ConfidentialityEnsuring complete privacy and confidentiality helps enable patients to feel comfortable discussing personal medical issues. Today many pharmacies are equipped with special counseling areas to address privacy issues. When counseling, pharmacists can reassure patients of privacy by monitoring voice levels and counseling patients away from the dispensing area when possible.
(9.) Tailor Counseling to Meet Patient Needs- The ability to tailor patient counseling to meet individual needs is critical. Pharmacists should be aware of patients with disabilities and be prepared to treat them with respect and understanding. Techniques should be tailored to accommodate the needs of each patient via verbal counseling or the use of visual aids and demonstrations when warranted. When the medication therapy involves certain administration techniques, such as the use of an inhaler, an injection, or a monitoring device, pharmacists should demonstrate the proper technique to ensure that patients are adequately trained.
(10.) Motivate Patients- Effective counseling not only provides patients with the pertinent information they need to use their medication correctly, it also motivates them to adhere to their medication regimens. Pharmacists can motivate patients by discussing the benefits of medication adherence, offering support, and explaining the pros and cons of treatment. For example, when counseling a patient with diabetes, in addition to teaching the patient about medications, the pharmacist can stress the importance of maintaining tight glycemic control to decrease or prevent the complications associated with diabetes. Pharmacists also can make suggestions, such as the use of medication reminder containers, to facilitate patient adherence. Information always should be relayed positively, and pharmacists should look continually for ways to inspire patients to learn more about their treatment plan.
2.2 WHY PHARMACISTS SHOULD COUNSEL PATIENTS? [25] Communicating with patients about their medications provides significant benefits to both the patient and the pharmacist. The 39 International Journal of Current Research and Review www.ijcrr.com Vol. 03 issue 05 May 2011 patient will have a better understanding of the purpose for the prescribed therapy and the appropriate use of the medication. This leads to several potential benefits:
Improved therapeutic outcomes and decreased adverse effects
• Improved patient adherence to the treatment plan
• Decreased medication errors and misuse
• Enhanced patient self-management by involving the patient in designing the therapeutic plan.
• Potential for decreased health care costs due to appropriate use of medications and prevention of adverse events.
2.3 NECESSITY OF PATIENT COUNSELING [26] Mock asserts that "the concept of effective clinician-patient communication is a necessity, not an option. Because commu¬nication is both a science and an art that can be learned and mastered, there are many resulting benefits for those who work diligently to improve their technique, not the least of which is increased clinician satisfaction." A recent incident was reported in New Brunswick where an incorrect medication was dispensed on transfer. The patient was not counseled and the error was identified by the caregiver when the patient was taking the medication later that night. Had the patient been shown the medication in the counseling process, the incident could have been immediately corrected. Much less harm is done by identifying medications errors before they leave the pharmacy. Therefore, health care profes¬sions education, and specifically pharmacy education, should include specific training in patient communication skills and an understanding of the psychological reactions to illness and treatment.
2.4 TECHNIQUES OF COUNSELING [17] Several techniques can be adopted for effective counseling. Some of them include providing written information to the patient and the use of audiovisual materials. The use of various compliance aids include labeling, medication calendars, drug reminder chart and providing special medication containers and caps can also be adopted. The United States Pharmacopoeia (USP) medication counseling behavior guidelines divide medication counseling into the following four stages (USP, 1997).
Stage I: Medication information transfer, during which there is a monologue by the pharmacist providing basic, brief information about the safe and proper use of medicine. Stage
Stage II: information exchange, during which the pharmacist answers questions and provides detailed information adapted to the patients‘ situation. Stage
Stage III: education, during which the pharmacist provides comprehensive information regarding the proper use of medicines in a collaborative, interactive learning experience. Stage
Stage IV:counseling, during which the pharmacist and patient have a detailed discussion intending to give the patient guidance that enhances problemsolving skills and assists with proper management
3. COUNSELING OF PATIENT AFTER FILLING PRESCRIPTION [28] After filling the prescription give some advice to the patient about how to use drugs. Some common advices are -
(i) Removing of Drug from the PackageTo the unaware patient, the pharmacist must demonstrate how the drug is to be removed from the package. This seemingly simple task may be quite confusing to some patients. Handling of Dropainer eye preparations, removal of dust cap from suppositories, opening of safety containers are some of the difficulties faced by the untrained patient.
(ii) Administering the Drug- The pharmacist should clearly mention to the patient, how and by which route the medicine has to be administered. The importance of this lies in the fact that inadequate information may lead to faulty administration and consequently to diminution or exaggeration of the desired effect. Consider the example of a tablet. There are at least 9 different ways a tablet can be administered depending upon the type of tablet and the drug it contains. These are (a) place on tongue and swallow with water, (b) chew and swallow (c) not to be chewed (d) let it dissolve in mouth and suck (e) sublingual, do not swallow (f) buccal, let it dissolve (g) dissolve in water and swallow (h) dissolve in water and use extremely (i) moisten with water and insert vaginally or rectally. Inadequate instructions in such cases will lead to wrong administration.
(iii) Ophthalmic preparations- For instillation of an eye drop, the pa¬tient is advised to tilt the head backward or if possible lie down looking up at the ceiling. He should hold the dropper above affected eye and allow a drop of the medicine to fall in the space between the eyeball and the inside the lower eye lid while looking up. The patient should be warned not to touch the tip of the dropper to any surface or the eye lid. The lower lid is released and the eye kept open without blinking for at least 30 sec. Thereafter, the patient is advised to apply gentle pressure with his fingers at the bridge of the nose for about I min to prevent drainage of solution from the eye. Eye preparations should be discarded after 1 month from the date of opening of the container. Eye ointments are administered in a similar manner; about l/4 to l/2 inch of the ointment from a squeezable tube is placed inside the lower eyelid.
(iv) Inhalations- The pharmacist must demonstrate the use of inhalers particularly to the new users, children and elderly. The inhaler requires shaking before use. It should be held between the index finger and the thumb so that the container is upside down. The patient is advised to hold the breath for as long as possible to derive the maximum benefit. The inhaler is removed from the mouth and exhalation is done slowly through pressed lips. Likewise, relevant instructions about the use of other dosage forms like suppositories, creams, lotions solutions etc. should be given to the patient.
(v) Timing of the dose- The pharmacist must use his knowledge of drugs when interpreting the directions of the physician and give in¬structions to the patient to ensure that the drug is maximally effective. If the drug has the propensity to cause GI upset, it is best taken with food or milk. If its bioavailability is affected by the presence of food, the drug should be taken 1 hr before or 2 hr after meals. If steady state blood levels are essential for the desired effect, the dosing schedule can be appropriately adjusted.
(vi) Duration of use- The duration of use of medication is dependent on the nature of the illness and the drug used. For chronic ailments, the length of drug intake is more. The greater the duration of drug intake, the greater is the problem of compliance. The patient is advised to take the medication regularly and visit the physician frequently to get the effectiveness of the therapeutic regimen assessed.
(vii) Storage- Proper storage conditions are necessary for safety and maintenance of the efficacy of drugs. All medication should be kept in a cabinet away from the reach of children. External and internal use preparation should be kept segregated. Exposure• of drug to extremes of temperature and humidity should be avoided. The medication should not be used after its date of expiration.
(viii) Side Effects- No drug is without side effects and it is necessary that the pharma¬cist makes some of the commonly occurring side effects known to the patient. However, the manner in which the pharmacist tells this to the patient is important. The pharmacist should not drive away the patient from using the medication or create a scare in him; rather the informa¬tion should be presented in a manner so as to encourage compliance. The pharmacist must also mention how to cope with these side effects if it is possible, e.g. headache with the use of metronidazole may be relieved by taking aspirin or paracetamol. For drugs which cause drowsiness, the patient should be advised against driving during the period of drug intake. With some drugs like metronidazole, the use of alcohol has to be avoided. The patient should be specifically cautioned against it. With some drugs the incidence of side effects decrease on continued use.
(ix) Drug Interaction- The patient should be clearly mentioned of the possible interaction of his prescribed drug with factors like food, tobacco smoking, alcohol consumption, and with other. Nonprescription drugs, that he may be taking. Unfortunately, there is a common notion, that all OTC drugs are safe. The pharmacist should dispel this notion and advise the patient accordingly
(x) Allergies- Careful documentation of the past medication history and ascer¬taining any known allergy to any drug will undoubtedly• reduce the incidence of druginduced allergies. However, since many drugs are foreign to the body, they do have the capability to cause allergy. This fact should be carefully detailed to the patient. The patient should be advised that if he experiences rashes, itching or burning of skin, he should discontinue the drug and consult the physician.
4. COUNSELING OF SOME COMMON DISEASE [29] (i) CORONARY HEART DISEASE [30] As with other chronic diseases, the aim of treatment is to reduce the mortality, morbidity and associated impairment in the quality of life. A pharmacist can play an active role in the management of this chronic illness in several ways.
Non-pharmacological measures: It includes education regarding diet, smoking, and exercise and encouraging the patients to maintain a diary on anginal attacks, pain symptoms etc.
Pharmacological measures: Educating the patients on the use of nitrates in case of an acute anginal attack is one of the important roles of pharmacists. Some of the important pharmacological measures are listed in (Table 1).
(ii) ASTHMA [31] Asthma is a chronic condition requiring lifelong drug therapy. Pharmacist can play an active role in counseling the patient regarding self monitoring of drug therapy, other life style modifications and usage of specialized dosage forms such as metered dose inhalers, dry powder inhalers, spacers etc.
Non-pharmacological measures: Safety measures while traveling, prophylactic use of drugs before exercise, avoidance of allergens, stopping cigarette smoking etc.
Pharmacological measures: Patient involvement in management of asthma is very important. Specific counseling on drug therapy should concentrate on three areas; drugs to relieve symptoms, drugs used to prevent asthma attack and those drugs which are given only as reserve treatment for severe attacks (Gibbs and Small, 2003). Training regarding use of the metered dose inhaler is one of the important roles of the counseling pharmacist. Some of the pharmacological measures to be included while counseling these patients are summarized in (Table 2).
(iii) DIABETES [32] Diabetes is a chronic disease with altered carbohydrate, lipid and protein metabolism (Kapur et al., 1998). The chronic complications of diabetes are known to affect the quality of life of diabetic patients. Various factors like understanding of the patients about their disease, dietary regulation, self-monitoring of blood glucose are known to play a vital role in diabetes management. Patient counseling and education are known to improve the quality of life of these patients (Rasheed et al., 2002). Some of the non-pharmacological and pharmacological measures are listed below.
Non-pharmacological approaches: The pharmacist can give an overview of diabetes, stress and psycho-social adjustment, family involvement and social support, nutrition, exercise and activity, monitoring and use of results, relationship between nutrition, exercise, medication, and blood glucose level.
Pharmacological measures: Studies suggest that the complications of diabetes can be reduced by tight glycemic control (The diabetes control and complications trial research group, 1993; UKPDS Group, 1998.The drugs used in diabetes are also known to possess certain peculiar features such as ?Taken half an hour before food? in case of Sulfonylureas; ?awareness of hypoglycemia? during insulin therapy etc. (Table 3) lists some of the important pharmacological measures a pharmacist should stress while counseling diabetic patients.
(iv) HYPERTENSION [32] Though hypertension is not a disease, it is known to be an important risk factor for several complications resulting in end organ damage (Thomas, 2003). If uncontrolled it can lead to a huge adverse impact on quality of life. The management of hypertension requires non-pharmacological as well as pharmacological methods (Chobanian et al., 2003).
Non-pharmacological measures: In many occasions nonpharmacological treatment alone may suffice in the management of hypertension. A pharmacist can counsel the patients regarding weight loss and regular exercise, sodium and calorie restriction, restriction of saturated fats and increased intake of dietary fibers, restriction of alcohol intake, smoking cessation, caution while using cold remedies containing sympathomimetics, self-monitoring of blood pressure etc.
Pharmacological measures: In a majority of patients, drug therapy is required. The patients often underestimate hypertension as by itself it usually does not exhibit any major symptoms. Thus non-compliance becomes very common. Added to this is the fact that many of the antihypertensive drugs causes side effects that are very serious such as Angiotension Converting Enzyme (ACE) inhibitors induced cough, beta blockers induced bradycardia etc. In some cases the dose modulation of the drugs is also very essential. Some of the pharmacological measures that can be taken by the pharmacist during counseling are listed in (Table 4).
5. STATUS OF PATIENT COUNSELING IN INDIA [32] Basic act of patient counseling will take miles ahead of the present pharmacy professional situation in India. Patient counseling in USA is very well comparing to India. USP medication counseling guidelines suggests four stages in counseling such as counseling introduction, content, process and counseling conclusion.USP has listed about 175 various counseling items that can be used during counseling. But in India condition to begin with, about 15 items may be sufficient. As per the need and time, few or all these items can be used. Following are the counseling items which are distributed into four stages such as counseling introduction, counseling content, counseling process, and counseling conclusion.
Englishhttp://ijcrr.com/abstract.php?article_id=2173http://ijcrr.com/article_html.php?did=21731. Roter DL, Hall JA, Merisca R, et al. Effectiveness of interventions to improve patient compliance: a meta-analysis. Med Care. 1998; 36:1138-61.
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5. Morris LA, Tabak ER, Gondek K. Counseling patients about prescribed medication: 12-year trends. Med Care. 1997; 35:996-1007.
6. Perri M, Kotzan J, Pritchard L, et al. OBRA '90: the impact on pharmacists and patients. Am Pharm. 1995; NS35:24- 28, 65. 46 International Journal of Current Research and Review www.ijcrr.com Vol. 03 issue 05 May 2011
7. Erickson SR, Kirking DM, Sandusky M. Michigan medicaid recipients' perceptions of medication counseling as required by OBRA '90. J Am Pharm Assoc. 1998; 38:333-8.
8. Schommer JC, Wiederholt JB. A field investigation of participant and environmental effects on pharmacistpatient communication in community pharmacies. Med Care. 1995; 35:567- 84.
9. Sleath B. Pharmacist-patient relationships: authoritarian, participatory, or default? Patient Educ Couns. 1996; 28:253-63.
10. Scott DM, Wessels MJ. Impact of OBRA '90 on pharmacists' patient counseling practices. J Am Pharm Assoc. 1997; 37:401-6.
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12. Nichol MB, Michael LW. Critical analysis of the content and enforcement of mandatory consultation and patient profile laws. Ann Pharmacother. 1992; 26:1149-55.
13. Kirking D. Evaluation of an explanatory model of pharmacists' patient counseling activities. J Soc Admin Pharm. 1984; 2:50-6.
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15. Svarstad BL, Mason H, Schuna A. Factor‘s affecting pharmacists' communication behavior: an observational study. Paper presented at: Annual Meeting of the American Association of Colleges of Pharmacy; July 1979; Denver, Col.
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18. Terrie YC, Review on 10 Behaviors of Effective Counselors Published Online: May 1, (EDT).
19. Rantucci, M. Pharmacists Talking With Their Patients: A Guide to Patient Counseling. 2nd Edition. Baltimore, MD: Lippincott Williams and Wilkins; 2006:3-4.
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Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-524135EnglishN-0001November30HealthcareEVALUATION OF AUDITORY ACUITY IN CROSSSECTIONAL POPULATION OF BANGALORE CITY
English4855Irshad AhamedEnglish Shaikh MohsinEnglishBackground and Objectives: Noise pollution in urban city like Bangalore is a serious problem
and steadily increasing over the years. The relationship between noise exposure and hearing loss
in normal subjects residing in urban city like Bangalore is yet to be investigated. The aim of this
study was to evaluate the auditory acuity in cross-sectional population of Bangalore city.
Methods: 219 normal subjects residing in noisy roads in four geographical areas belonged to test
group and 52 normal subjects residing in silent area belonged to control group were subjected to a
pure tone audiometric assessment. The resulting data was statistically analyzed with SPSS
software. Results: The auditory thresholds in most of subjects residing in noisy areas were higher
at the frequencies 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz in both ears when compared
with subjects residing in residential area. This was suggestive of increase prevalence of
sensorineural hearing loss among subjects of noisy area. Conclusion: Subjects residing in noisy
areas have an increased risk of noise induced hearing loss. The duration of exposure to noise had
a direct effect on degree of hearing impairment in subjects of noisy area.
Englishaudiometry, hearing loss, noiseINTRODUCTION
Development in technology, commerce, communication and education has enhanced the urban growth both in developed and developing countries1 . There have occurred many environmental problems in the city like Bangalore with increased urbanization and noise has emerged as one of major environmental problems. Noise can be defined as any unwanted, disturbing or harmful sound that impairs or interferes with hearing, causing stress and hampers concentration2 . Noise pollution emanates from both outdoor and indoor environment and major contribution to outdoor noise often comes from road transportation which is the main source of pollution. Noise survey in various cities throughout the world has revealed that traffic noise is typically the largest contributor to recorded sound levels and the most important source of annoyance2 . Of the more than 28 million Americans with some degree of hearing impairment, as many as 10 million have hearing loss caused in part by excessive noise exposure3 . The noise levels in Mumbai vary between 75-90 decibels that peaks to 100 dB during festive seasons and in Kolkata the noise levels reaches above 100 dB at busy streets4 . A recent study by Mysore based All India institute of speech and hearing (AIISH) has found that noise levels in all major roads in Bangalore city are over 80 dB while permissible levels are only 65 dB5 . It has been well established that exposure to traffic noise causes annoyance, hearing loss, mental disorders and adverse physiological and psychological impacts. The situation of Bangalore due to rapid urbanization needs to be investigated, which may be one of the precipitating factors of increased stress related disorders. Diagnostic audiometry comprises of tests which detect conductive and sensorineural hearing loss. Pure tone audiometry involves the estimation of threshold of hearing for certain standardized stimuli via the air and bone conduction routes6 . An audiometer, being a fundamental tool in the diagnosis of auditory capacities has been employed to evaluate auditory acuity in cross sectional population in different areas of Bangalore city.
MATERIALS AND METHODS The study was conducted in a sample of 271 normal subjects after informed, written and verbal consent in Bangalore between April to September 2006. They were divided into two groups. Group 1comprises of 219 normal subjects working in noisy roads in four geographical areas (West, North, South and East). The West, North, South and East area was recognized as Noisy area No. 1, 2, 3 and 4 respectively which include 56, 56, 54 and 53 subjects respectively. The selection of subjects was based on fact that they were staying in different noisy areas (exposed to traffic noise for 8 hours/day or more for duration of 10 years or more). This group includes street-vendors, shopkeeper of the roadside, traffic policemen, drivers and conductors of Bangalore Metropolitan Transport Corporation (BMTC). Group 2 comprises of 52 normal subjects which was relatively silent when compared with above four areas. This area was recognized as Residential area. The selection of subjects was based on fact that they were staying in specific residential areas for 8 hours/day or more for duration of 10 years or more. This group includes house wives, shop keepers of this area. The selection of subjects is based on inclusion-exclusion criteria. Inclusion criteria includes age group between 20 to 50 yrs and subjects who are staying in selected noisy and silent areas for at least ten years while the patients suffering from hypertensive, Diabetes or patients using ototoxic drugs since last 3 months or having history of ear surgeries or recent ear, nose, throat infection were excluded. The Pure Tone Audiometry (PTA) was conducted on all subjects with the help of audiometer and results were noted. The selected subject was required to answer a detailed questionnaire exploring their hearing status7 . He was also subjected to an otological examination to rule out any external and middle ear pathologies. A detailed general physical and systemic examination is done on the subject and he is taken to the sound proof room for an audiometric testing. The method is based on American Society for Speech and Hearing Association [ASHA] 1978 guidelines for PTA. Masking (Masking PTA) is done to mask the ear not under test and when the air bone gap of the poorer ear under test is more than 10 dB8 . Interpretation of an audiogram suggests three types of deafness 7 . Conductive deafness is indicated by raised air conduction thresholds (>25 dB) and a 50 International Journal of Current Research and Review www.ijcrr.com Vol. 03 issue 05 May 2011 normal bone conduction threshold with a wide air- bone gap of 15 dB or more. Sensorineural deafness is indicated by raised air and bone conduction thresholds (both >25 dB) and the air bone gap does not exceed 10 dB, while Mixed deafness is indicated by air and bone conduction thresholds was raised (both >25 dB) with an air bone gap of greater than 15 dB. Degree of hearing loss was noted as per WHO classification8 . Data were analysed using SPSS software
RESULTS
In the present study, there are two groups of subjects, one group consisting of 219 normal subjects residing in noisy roads in four geographical areas (west, north, south, east) and other group consisting of 52 normal subjects staying in relatively silent (residential area). Table no. 2 to 7 shows the results of the subjects working in noisy i.e. the test group and the subjects residing in residential area i.e. the control group. It was prepared and rearranged as per requirement of the parameters discussed. It is important to first appreciate that the noise levels in urban city of Bangalore are above 80 dB in all major roads which is above permissible levels5 . The actual effect of noise on auditory acuity of normal subjects residing in noisy roads is unknown. In this study, the test group (subjects belonging to noisy area 1, 2, 3, 4) and control group (subjects belonging to residential area) have been selected and matched with respect to age ( table1), to remove the effect of presbycusis9 . It is of prime importance to appreciate that noise induced hearing loss develops gradually and noise can cause permanent hearing loss at chronic exposure of 85 dB or higher for an eight hour period3 . It is said that 10 years or more of exposure is generally required for significant hearing loss to occur. Hence in present study only those subjects from both control (residential area) and test group (noisy area) were selected who were staying in the respective area for a minimum of 10 years and exposed to noise for a period of 8 hrs/day. It is evident from tables 2 to 5 that the auditory thresholds of subjects residing in the noisy roads are above 25 dB at frequency 1000 to 8000 Hz and increase in threshold progresses through frequencies 1000 to 6000 Hz reaching maximum level at 4000 Hz and relatively lower at 8000 Hz, when we compare the hearing thresholds of the subjects in each noisy area (1 to 4) versus residential area (5) (PEnglishhttp://ijcrr.com/abstract.php?article_id=2174http://ijcrr.com/article_html.php?did=21741. Joshi SK, Devkota S, Chamling S, Shrestha S. Environmental noise induced hearing loss in Nepal. Kathmandu University Medical Journal (2003) Vol. 1, No. 3, 177-183.
2. Ingle S T, Pachpande B G. Monitoring and assessment of daily exposure of residentialpopulation to highway traffic noise in Jalagaon urban center. [access date 2006 April 22]. Available from: URL: http://www.iasi.cnr.it/ewgt/16 conference/ID85.pdf
3. Rabinowitz P M. Noise induced hearing loss. American academy of family physicians. 2000 May 1; 61:2749-56, 2759-60.
4. Case draft dossier: Health and environment>> A. Environment and diseases 4. Noise pollution: Deafening decibels. [Access date 2006 June 23]. Available from: URL: http://www.cseindia.org/programme/heal th/pdf/conf2006/a4noise.pdf
5. Noise City. Noise pollution can lead to several health risks. Deccan Herald. 2006 June 16. [access date 2006 August 20]. Available from: URL: http://www.deccanherald.com/deccanher ald/jun162006/editpage.asp
6. Kerr A G, Stephans D. Scott-Brown‘s Otolaryngology: Adult Audiology; volume 2; 6th edition, pp 2/1/6-9, Butterworth Heinemann, 1997.
7. Sanders J W, Katz J. Silverman‘s text book of audiometry. pp 10-65, Williams and Wilkins 1982.
8. American speech and hearing Association, committee on audiometric evaluation (1978a). Guidelines for manual pure tone threshold audiometry. Asha, 20: 297-301.
9. Jorgensen M B. Histological studies on changes of aging in the inner ear. Arch Otolaryngol 1961; vol 74(Aug): 56-62.
10. Patwardhan M S, Kolate M M, More T A. To assess effect of noise on hearing ability of bus drivers by audiometry. Indian J Physiol Pharmacol. 1991 Jan;35(1):35-8.
11. Lee L T. A study of the noise hazard to employees in local discotheques. Singapore Med J. 1999 Sep; 40(9):571- 4.
Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-524135EnglishN-0001November30HealthcarePHENOTYPING - AN OVERVIEW
English5663Kavita AtreEnglish Rahul MayeeEnglish Sanjay ToshniwalEnglishThe medicinal sciences have always aimed at an increased effort to increase the patient safety and reduce medical errors. These errors are mainly caused due to therapeutic failure and adverse drug
reactions which arise as a result of incorrect dosing of the routinely prescribed drugs. The drugs
are metabolized by drug metabolizing enzymes of which the Cytochrome P450 enzyme forms a
major class. It is now being observed that with the descriptions of genetic polymorphism in the
drug metabolizing enzymes, the field of pharmacogenetics may improve medical care through a
reduction in adverse drug reactions oriented errors. The status of these drug metabolizing
enzymes can be characterized using phenotyping studies which categorizes the population into
poor, extensive or ultra-extensive metabolizers. Such a division of population based on their
metabolic status will be of immense help to the medical authorities in deciding the drug dose.
This paper reviews the field of Cytochrome P450 (CYP) genetics and explores factors that impact
the utility of this information in clinical practice to avoid incidences occurring due to incorrect
metabolism of the routinely prescribed drugs.
EnglishPhenotyping, Cytochrome P450, Drug metabolismINTRODUCTION
The two areas that significantly represent patient‘s safety concern are – therapeutic failure and adverse drug events (ADEs). [1] Therapeutic failure refers to lack of efficacy due to lack of dosing where as ADEs include both compliance issues and medical dispensing errors. [2] On the other hand, adverse drug reactions (ADRs) are the complications that occur despite appropriate dispensing of the correct medication at the ?intended dose?. The ADEs are usually caused when there is presence of excess drug in the body for a time longer than is necessary. The drug outcome is mostly based upon the genetic make-up of an individual which is likely to exhibit inter-individual difference in population owing to ?genetic polymorphism?. [3] Hence, the intended dose might not prove appropriate for every individual.
Studying polymorphic drug metabolism in a population helps to categorize individuals based on their ability to metabolize routinely prescribed drugs. Such studies are referred to as ?phenotyping studies? and they are carried out by using an appropriate drug as a substrate for the respective enzymes and determining the drug-metabolite ratio. Based on this ratio the population is categorized into poor, extensive or ultra-extensive metabolizers. These phenotyping studies would be an immense help to medical and therapeutic sciences to have prospective access to genetic information that might predict efficacy and/or toxicity of an individual for respective drugs.
Drug metabolism and Cytochrome P450 (CYP) Enzyme System: Drugs are almost all xenobiotics. Drug metabolism is metabolism of drugs, their biochemical modification or degradation, usually through specialized enzymatic systems. Drug metabolizing enzymes (DMEs) often convert lipophilic chemical compounds into more readily excreted polar products. This drug metabolism can result in toxication or detoxication – the activation or deactivation of the chemical. Drug metabolism is typically classified as Phase I and Phase II reactions. Phase I reactions are biotransformation reactions that alter the structure of the parent drug converting it to subsequent metabolites. Phase II reactions are usually known as conjugation reactions and they modify the drug covalently making it less toxic to body. Both Phase I and Phase II DMEs can impact a drug‘s activity.
Phase I DMEs include esterases, dehydrogenases, flavin monooxygenases and the Cytochrome P450 (CYPs). [4] Cytochrome P450 (CYP450) enzymes are essential for the production of cholesterol, steroids, prostacyclins, and thromboxane A2 and are located in the membranes of the smooth endoplasmic reticulum. They also are necessary for the detoxification of foreign chemicals and the metabolism of drugs. CYP450 enzymes are so named because they are bound to membranes within a cell (cyto) and contain a heme pigment (chrome and P) that absorbs light at a wavelength of 450 nm when exposed to carbon monoxide. There are more than 50 CYP450 enzymes, but the CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP3A4, and CYP3A5 enzymes metabolize 90 percent of drugs. [5, 6] out of these six enzymes, CYP2D6 and CYP3A4 is found to have maximum activity of 40% and 20% respectively [7] These enzymes are predominantly expressed in the liver, but they also occur in the small intestine (reducing drug bioavailability), lungs, placenta, and kidneys. [6]
Genetic Polymorphism and Cytochrome P450: Genetic Polymorphism is defined as the inheritance of a trait controlled by a single genetic locus with two alleles , in which the least common allele has a frequency of about 1% or greater. [7] One of the most extensively studied genetic polymorphism is the polymorphism observed in drug metabolizing enzymes. These changes in gene expression accompany drugmetabolizing enzyme gene polymorphism and cause alteration in enzymatic activity showing a gene-dosage effect. Genetic polymorphism has been found to categorize people into three different types of phenotypes based on their extent or capability to metabolize a drug. Normal population is usually an extensive metabolizer (EM); poor metabolizers (PM) show accumulation of the specific drug substance hinting at the deletion of or mutation in both alleles for phenotypic expression whereas ultra extensive metabolizers (UEM) exhibit an increased drug metabolism which is an autosomal dominant trait arising from gene amplification. [8] A specific gene encodes each CYP450 enzyme. Every person inherits one genetic allele from each parent. Alleles are referred to as ?wild type? or ?variant,? with wild type occurring most commonly in the general population. An ?extensive? (i.e., normal) metabolizer has received two copies of wild-type alleles. Polymorphism occurs when a variant allele replaces one or both wild-type alleles. Variant alleles usually encode a CYP450 enzyme that has reduced or no activity. [9] Persons with two copies of variant alleles are ?poor? metabolizers, whereas those with one wild-type and one variant allele have reduced enzyme activity. Finally, some persons inherit multiple copies of wild-type alleles, which results in excess enzyme activity. This phenotype is termed an ?ultra extensive? metabolizer. [10]
CYP450 enzyme polymorphism is responsible for observed variations in drug response among patients of differing ethnic origins. [10, 11, 12] For example, 7 percent of white persons and 2 to 7 percent of black persons are poor metabolizers of drugs dependent on CYP2D6, which metabolizes many beta blockers, antidepressants, and opioids. [13, 14] One in five Asian persons is a poor metabolizer of drugs dependent on CYP2C19, which metabolizes phenytoin (Dilantin), phenobarbital, omeprazole (Prilosec), and other drugs. [15] Variance in drug response among persons of different ethnic origins also can be caused by genetic variations in other drug-metabolizing enzymes, drug transporters, and drug receptors. [16] The understanding of gene dosage effect related to the function changes of genetic polymorphisms of drug metabolizing enzymes, transporters and receptors not only provide potential novel insight into the effect of genetic polymorphisms on drug efficacy and toxicity but also point to the potential role of it in genotype directed tabloid drug therapy. Even though the additional larger and controlled studies are needed to justify changes of treatment strategies, the pharmacogenetics approach to individualize therapy in some patients is promising.
Phenotyping: Phenotyping is one of the most common methods used to study genetic polymorphism. It requires intake of a probe drug; the metabolism of which is known to be solely dependent on one of the Cytochrome P450 (CYP) enzymes such as CYP2D6, CYP3A4 etc. The excretion of parent compound and/or metabolite in urine is used to calculate the metabolic ratio, which is the measure of individual‘ respective enzyme activity. [18, 19] Phenotyping studies can also be carried out by analyzing blood or saliva samples. [20, 21] This phenotyping study divides the population as per their genetic polymorphism into poor, extensive or ultra extensive metabolizers and thus can be used in deciding the drug dose for each individual. Defining the individual‘s phenotype, relative to a reference substrate, allows the drug metabolism phenotype for other substrates of that enzyme to be predicted easily. [22]
Significance of phenotyping studies: The clinical importance of various CYPs and their genetic polymorphisms has paved way for a new fields- ?Pharmacogenetics? and ?Pharmacogenomics?. The traditional pharmacogenetic approach relies on studying sequence variations in candidate genes suspected of affecting drug response. On the other hand, pharmacogenomic studies encompass the sum of all genes, i.e., the genome. Thus, it can be said that pharmacogenomics has evolved from the academic science, pharmacogenetics, which focused primarily on genetic polymorphisms in DMEs. The "one drug fits all" approach of the Pharma industry could, with the fruits of pharmacogenomic research, evolve into an individualized approach to therapy where optimally effective drugs are matched to a patient's unique genetic profile. [23]
Standard drug doses may cause adverse effects related to elevated drug serum levels if a person is a poor metabolizer or has a CYP450 enzyme inhibitor added to therapy. [24, 25] Adverse effects are more likely to occur if a drug has a narrow safety range or is dependent on only one enzyme for metabolism. This can be best explained by the following illustrations.
Illustration 1: A 35-year-old white woman with panic disorder was treated with paroxetine (Paxil). She developed unrelated hypertension, for which the physician prescribed 50 mg daily of extended-release metoprolol (Toprol XL). The patient became symptomatically orthostatic after a few days and presented to the emergency department. In this example, metoprolol, which is metabolized solely by CYP2D6, was present in higher serum levels in the patient because of the use of paroxetine.
Peak serum levels of simvastatin (Zocor), which is metabolized solely by CYP3A4, also can increase by many times in patients who are poor metabolizers or with the addition of a potent inhibitor, increasing the risk of myopathy and rhabdomyolysis at usual doses. [26]
Illustration 2: The linkage between the HER2/neu oncogene and the efficacy of Herceptin® for the treatment of advanced breast cancer is another example where pharmacogenomics has proven successful. Profiling of subjects with breast tumours expressing HER2/neu (class 2-3 HER2/neu immunohistochemitsry staining) was utilised to compare clinical efficacy in late stage drug development with those individuals most likely to respond to therapy. [27] The linkage between HER2/neu levels assessed by a diagnostic test and selection of therapy with Herceptin® is one of the first pharmacogenomic applications approved by the FDA. [28] This is also an excellent example demonstrating that each patient (and his disease) is highly variable, requiring treatment based on the expression of tumour genes. Only 25 - 30% of all breast cancers overexpress HER2/neu, effectively segmenting the market for Herceptin®. However, physician and patient confidence in selecting this therapy based on a prospective pharmacogenomic approach will actually result in better disease management and compliance.
Ultimately, this approach will mean that positioning and differentiation of drug treatment will allow drugs that would otherwise not be approved to be used in a select population of patients, with premium pricing and better acceptance. [28]
Methodologies used in phenotyping: Probe substrates (or probe drugs) are compounds that are predominately or exclusively metabolized in vitro by an individual CYP enzyme. [29] The metabolism of the candidate probe is generally characterized through the use of preparations containing individually expressed human CYP enzymes or preparations of human liver microsomes. [30] Drugs that are selectively metabolized and that can be safely administered to humans may be used as in vivo probe drugs for the purposes of phenotyping i.e., estimating CYP enzyme activity.
1) Single drug probes- The phenotyping procedure typically involves the administration of the probe drug and the collection of blood and/or urine in order to determine some measure of the enzyme‘s functional activity. Typically, as small a dose of the probe drug as possible is administered so as to avoid or minimize undesirable clinical effects. An index of enzyme activity, also referred to as a phenotypic trait measure, is chosen to reflect the catalytic activity of a single pathway of metabolism. The intrinsic clearance of a probe or of the metabolite(s) produced, termed formation clearance, is the most appropriate measure of enzyme activity. [31]
2) Cocktail method- Administering multiple probe compounds concomitantly, termed the ?cocktail? strategy, is a useful method in the assessment of drug-metabolizing enzyme activities because it allows for the in vivo assessment of multiple pathways of drug metabolism in a single experiment. [32] The utility of the cocktail strategy, first demonstrated by Schellens and Breimer in multiple investigations, offers several potential advantages in that it reduces participation time for the study subjects and increases efficiency for the investigators by decreasing time and expense. [32] More importantly, this approach minimizes intra-individual variability since the evaluation will occur on one day rather than separate days. Phenotypic data (i.e., enzyme activity) can be obtained simultaneously on multiple pathways while genetic material obtained can be examined for known or novel SNPs in the drugmetabolizing enzyme genes. Thus, the cocktail strategy appears to be an invaluable method to investigate differential modulation of CYP activity. [33]
Current status of phenotyping: Around the world- Several phenotyping studies have been conducted around the globe to determine the phenotype status of an individual. These studies have not only been conducted for different population in various parts of the world but also with respect to different CYP enzymes. Based on these studies different percentages of PM, EM and UEM have been obtained for different enzymes based on the inter-ethnic differences in the population. For example, CYP2C19 the prevalence of PMs has been reported to be 2–5% in Caucasians [34, 35] 4–8
% in Africans [36] and 11–23 % in Orientals. [35]
In Maharashtra: As far as the state of Maharashtra goes, only one such phenotyping study has been conducted in the Mumbai. This study was conducted to study the genetic polymorphism in CYP2C19 enzyme in the Gujrathi and Marwadi population of the Mumbai region. The probe drug used to estimate the enzyme activity was omeprazole (20 mg) whose drug metabolite is 5-hydroxyomeprazole. The DM ratio analyzed on HPLC (High Performance Liquid Chromatography) led to the generation of the phenotyping data. It was seen that 10.36% of this population were poor metabolizers (PM) whereas 89.63% were extensive metabolizers (EM). [36]
CONCLUSION
Genetic polymorphism appears to be a significant source of variability observed in the response to drugs. This variability means that information pertaining to interethnic and inter-individual genetic differences can be used to facilitate rational drug discovery and development and to avoid or minimize the incidence of adverse events in clinical trials. Thus, one could generate criteria for selecting patients most likely to benefit from a drug without incurring unnecessary risk. In this review we have seen the clinical application of phenotyping data as they apply to the clinical laboratory as well as to the clinical practitioner. Phenotyping may be indicated in each instance when the therapeutic of choice is a substrate for a polymorphic enzyme. Alternatively, genotyping is indicated when individuals demonstrate suboptimal response to drugs that are substrates for polymorphic enzymes. The advantage of combining phenotyping with therapeutic drug monitoring is that genotyping can predict the PM or UEM drug metabolism phenotypes, and this information can be used in prior dose adjustment or selection of an alternative therapeutic that is not a substrate for the polymorphic enzyme. The cost/healthcare effectiveness of these paradigms has not been extensively studied. Although there would be considerable cost associated with screening all individuals before dosing with these drugs, this cost may be offset by a reduction in costs associated with toxic episodes or therapeutic failure and subsequent intervention.
Englishhttp://ijcrr.com/abstract.php?article_id=2175http://ijcrr.com/article_html.php?did=21751. Kohn LT, Corrigan JM, Donaldson MS, Eds. To err is human: building a safer health system (Washington). Natl Acad Press. 1999.
2. Institute of Medicine. Crossing a quality chasm: a new health system for twenty first century (Washington). Natl Acad Press. 2001
3. Ingelman-Sundermann M. Genetic polymorphism of CYP450 2D6: clinical consequences, evolutionary aspects and functional diversity. Pharmacogenomics J.2005; 5:6-13.
4. Ingelman- Sunderberg M. Phamacogenetics of Cytochrome P450 and its applications in drug therapy: the past , present and future. Trends Pharmacol Sci. 2004; 25(4):193-200.
5. Wilkinson GR. Drug metabolism and variability among patients in drug response. N Engl J Med. 2005;352:2211–2221.
6. Slaughter RL, Edwards DJ. Recent advances: the cytochrome P450 enzymes. Ann Pharmacother. 1995;29:619–624. 62 International Journal of Current Research and Review www.ijcrr.com Vol. 03 issue 05 May 2011
7. Evans WE, Relling MV. Pharmacogenimics: translating functional genomics into rational therapeutics. Science. 1999;286:487- 491.
8. Lennard MS. Genetic Polymorphism of sparteine/debrisoquine oxidation: A reappraisal. Pharmacol Toxicol 1990;67:273-283.
9. Nebert DW. Pharmacogenetics: 65 candles on the cake. Pharmacogenetics. 1997;7:435-440.
10. Wilkinson GR. Drug metabolism and variability among patients in drug response. N Engl J Med. 2005;352:2211–2221.
11. Phillips KA, Veenstra DL, Oren E, Lee JK, Sadee W. Potential role of pharmacogenomics in reducing adverse drug reactions: a systematic review. JAMA. 2001;286:2270–2279.
12. Bradford LD. CYP2D6 allele frequency in European caucasians, Asians, Africans, and their descendants. Pharmacogenomics. 2002;3:229–243.
13. Special report: genotyping for cytochrome P450 polymorphisms to determine drug-metabolizer status. Technol Eval Cent Asses Program Exec Summ. 2004;19:1–2
14. Abraham BK, Adithan C. Genetic polymorphism of CYP2D6. Indian J Pharmacol. 2001;33:147–69.
15. Bernard S, Neville KA, Nguyen AT, Flockhart DA. Inter-ethnic differences in genetic polymorphisms of CYP2D6 in the U.S. population: clinical implications. Oncologist. 2006;11:126–135.
16. Chong E, Ensom MH. Pharmacogenetics of the proton pump inhibitors: a systematic review. Pharmacotherapy. 2003;23:460–471.
17. Weinshilboum R. Inheritance and drug response. N Engl J Med. 2003;348:529–537.
18. Linder MW, Prough RA, Valdes R Jr. Pharmacogenetics: a laboratory tool for optimizing therapeutic efficiency. Clin Chem. 1997;43:254-266.
19. Kroemer HK, Eichelbaum M. ?it‘s the genes stupid? molecular basis and clinical consequences of Cytochrome P450 2D6 polymorphism. Life Sci. 1995;56:2285-2298.
20. Hou ZY, Pickle LW, Mayer Sp, Woosley RL. Salivary analysis for determination of dextromethorphan metabolic phenotype. Clin Pharmacol Ther. 1991;49:410-419.
21. Hou ZY, Chen CP, Yang WC, Lai MD, Buchert ET, Chung GM et al. determination of dexromethorphan metabolic phenotype by salivary analysis with a reference to genotype in Chinese patients receiving renal hemodialysis. Clin Pharmacol Ther. 1996;59:411-417.
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24. Bradford LD. CYP2D6 allele frequency in European caucasians, Asians, Africans, and their descendants. Pharmacogenomics. 2002;3:229–243.
25. Meyer UA. Pharmacogenetics and adverse drug reactions. Lancet. 2000;356:1667–1671. 63 International Journal of Current Research and Review www.ijcrr.com Vol. 03 issue 05 May 2011
26. Ballantyne CM, Corsini A, Davidson MH, Holdaas H, Jacobson TA, Leitersdorf E, et al. Risk for myopathy with statin therapy in highrisk patients. Arch Intern Med. 2003;163:553–564.
27. Shak S: Case study: Genetech and the development of Herceptin. Second Annual Pharmacogenomics Event. European Centre for Pharmaceutical Information. 2000.
28. Anderson WH, Fitzgerald CQ, Manasco PK: Current and future applications of pharmacogenomics. New Horizons. 1999;7:262-269.
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37. Panchabhai TS, Noronha SF, Davis S, Shinde VM, Kshirsagar NA, Gogtay NJ. Evaluation of the activity of CYP2C19 in Gujrati and Marwadi subjects living in Mumbai. BMC Clin Pharmacol. 2006; 6:8.
Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-524135EnglishN-0001November30General SciencesBIOACCUMULATION OF MERCURY AND CHROMIUM IN A FRESHWATER FISH CLARIAS BATRACHUS
English6472Mary Josephine Rani AEnglish John Milton MCEnglish Uthiralingam M English Azhaguraj REnglishIn the present study Clarias batrachus was exposed to sublethal concentrations (~10% of 96 h-
LC50) of mercury (0.080ppm) and chromium (10.2ppm) were investigated for 28 days under
laboratory conditions. The concentrations of these metals in the various organs were detected
through Inductively Coupled Plasma–Atomic Emission Spectrometer (ICP-AES). The
concentration of mercury was high in brain (656.82ppb) followed by gills (287.63ppb), liver
(229.64ppb), kidney (176.44ppb) and muscles (49.21ppb) where as in the fishes exposed to
chromium, the concentration was high in gills (315.21ppb) followed by liver (241.4ppb), kidney
(187.96ppb), brain (128.29ppb) and muscles (51.3ppb).The ability of mercury and chromium as
toxicants was proved in the present study as the concentrations was found to be high in brain and
gills respectively.
EnglishClarias batrachus, heavy metals, ICP-AESINTRODUCTION
Over the last few decades, there has been growing interest in determining heavy metal levels in the aquatic environment and attention was drawn to the measurement of contamination levels in public food supplies, particularly fish. Metals are nonbiodegradable and are considered as major environmental pollutants causing cytotoxic, mutagenic and carcinogenic effects in animals (Kamaruzzaman, et al., 2010). Heavy metal contamination may have devastating effects on the ecological balance of the recipient environment and a diversity of aquatic organisms (Farombi, et al., 2007). Mercury, the black listed element by environmentalists, is released into the environment by several sources, such as mining and fossil fuel combustion, thermal power project, by the use of fungicides, bactericides and pharmaceuticals (Khangarot, 2003). A great deal of research concerning the effects of mercury on terrestrial and aquatic biota has demonstrated the potential risk that it represents because of its toxicity, accumulation and its tendency to biomagnify and also because of its properties like mobility and transformation in the environment, and its presence in humans (Francisco, 2004). Mercury in the organic form is the most toxic as it passes the blood brain barrier owing to its lipid solubility (Farhana et al., 2005). These heavy metal ions can exert their toxic effect through the gills, liver, kidney and brain (Velma et al., 2009). Chromium is widely used in industries, like leather tanning, electroplating, paint and pigment manufacturing, textile and fertilizers (Cervantes et al., 2001). Hexavalent chromium a heavy and poisonous ion is widely used, in manufacturing of steel as an electroplated coating for corrosion prevention; as a mordant in the textile industries; as an anticorrosive agent in the tanning industry, as catalyst for the manufacture of pigments and paints; in fungicides and wood preservatives and in anodization of aluminum in the aircraft industry ( Velma et al ., 2009).The hexavalent form is considered as the toxic form of chromium because it readily crosses cell membrane. Inside the cell, the hexavalent form is reduced to the trivalent form which complexes with intracellular macromolecules, including genetic material, and is ultimately responsible for the toxic and mutagenic capacities of chromium . The bioaccumulation of heavy metals and their toxic effects have been reviewed by Waqar 2006; Rasmussen and Anderson, 2000. Aquatic organisms have the ability to accumulate heavy metals from various sources including sediments, soil erosion and runoff, air depositions of dust and aerosol and discharges of waste water (Labonne et al., 2001). Therefore, accumulative capacity of aquatic organisms can pose a long lasting effect on biogeochemical cycling in the ecosphere. Heavy metals can also adversely affect the growth rate in different fishes (Hayat et al., 2007). The organisms developed a protective defense against the deleterious effects of essential and inessential heavy metals and other xenobiotics that produce degenerative changes like oxidative stress in the body (Abou EL-Naga et al., 2005; Filipovic and Raspor, 2003). Clarias batrachus (Linn.) is an air-breathing catfish, C. batrachus occurs in fresh and brackish waters throughout India. It is highly valued as a table fish throughout the Indian subcontinent and is preferred for culture even in muddy and shallow waters (Debnath and Surajit, 2009). The present study was carried out for a period of 28 days to determine the bioaccumulation of mercury and chromium in the various organs of Clarias batrachus.
MATERIALS AND METHODS
Healthy living specimens of Clarias batrachus were procured, from Bharath Fish Seed India, Poondi, Thiruvallur district, Tamilnadu. C. batrachus measuring 9.5+ 0.5cm in length and weighing 5 + 0.5 gram were used in the experiment. The fishes were acclimatized to the laboratory conditions for 20 days prior to experiment in a glass aquarium (40 x 40 x 100 cm) filled with dechlorinated water. Water quality characteristics were determined. The mean values for the test water qualities were as follows, temperature 27.5±1.5C°, pH 7.5±0.03, dissolved oxygen 6.4±0.2mg/l, alkalinity 250±2.8mg/l as calcium carbonate(CaCo3), total hardness 456±3.5mg/l. Stock solutions of mercuric chloride and potassium dichromate were prepared by dissolving analytical grade mercuric chloride (HgCl2 from Merck) and potassiumdichromate (K2Cr2O7·7H2O from Merck) respectively in double distilled water. Acute toxicity test was conducted in accordance with standard methods (APHA, 1995). Sublethal or safe level concentrations were derived from 96 hours Lethal Concentration 50 (LC50) as per the procedure described by Finney (1971). The 96h LC50 were selected as sublethal concentrations for mercury (0.080ppm), chromium (10.2ppm) and ten fishes of same size were exposed to each concentration with three replicates for a period of 28 days. A control batch corresponding to each test group was simultaneously maintained. The experiments were repeated five times for each test concentrations. To maintain a constant toxic concentration in the media, the water medium with appropriate concentration of heavy metal was changed every day. Fish were fed with commercial pelleted diets ad libitum. After 28 days the gills, liver, kidney, brain and muscle tissues of control and treated C. batrachus were dissected and dried, the samples were processed for acid digestion by using perchloric acid and nitric acid in the ratio1:3. The digested tissue samples were made up to 25 ml and 1 ml of the sample was introduced into Inductively Coupled Plasma–Atomic Emission Spectrometer (ICP-AES) (ISA JOBIN YVON 24 MODEL). The obtained data were tabulated in order to get bioaccumulation in ppb levels (Topping, 1973).
RESULTS
The median lethal concentration (LC50) of mercury to Clarias batrachus for 24, 48, 72 and 96 hours of exposure are 1.4 ppm, 1.2 ppm, 1.0 ppm and 0.8 ppm respectively (Table 1). The LC50 value of chromium to C. batrachus for 24, 48, 72 and 96 hours of exposure are 120 ppm, 115 ppm, 110 ppm and 102 ppm respectively (Table 1). Increase in exposure period results in decreased LC50 values. The sublethal concentrations (~10% of 96 h-LC50) of mercury (0.080ppm), (~10% of 96 h-LC50) chromium (10.2ppm) were treated to C. batrachus for 28 days. Table 2 and figure 1 summarise the bioaccumulation of mercury and chromium in ppb levels in the various organs of control and treated Clarias batrachus. It is evident from the table that both mercury and chromium are consumed by the fish from the surrounding medium and accumulated in the various organs. In the mercury treated tissues of C. batrachus, the bioaccumulation was significantly higher in the brain (656.82 ppb) and lower in the muscles (49.21 ppb). The levels of mercury accumulation in the gills, liver and kidney were 287.63 ppb, 229.64 ppb and 176.44ppb respectively. The bioaccumulation of mercury in the tissues followed the order: Brain> Gills > Liver > Kidney > muscle. Bioaccumulation of chromium was significantly high in the gills (315.21.ppb) and low in the muscle (51.30 ppb). The levels of chromium accumulation in the liver, kidney and brain were 241.4 ppb, 187.96ppb and 128.29ppb respectively .The bioaccumulation of chromium in the tissues followed the order: Gills > Liver > Kidney > Brain > muscle.
DISCUSSION
Metals cannot be metabolized and therefore have the potency to accumulate in the body, leading to chronic effects. The only way in which the metals can be eliminated is by excretion. The rate and pathway of excretion vary greatly from one metal to another and between different tissues (Goyer, 1992).
According to Ferard et al. (1983) aquatic organisms take up heavy metals and concentrate in amounts considerably higher than found in the environment. Measurement of metals in aquatic environment is an important monitoring tool to assess the extent of pollution of the aquatic biotopes (Kumar and Mahadevan, 1995). The field of heavy metal detection by ICP-AES in the industrial waste and soilsediment is still very much in the stage of development (Shrivastava and Chaudhary, 2000). ICP-AES determination of metals is of high sensitivity and accuracy with low matrix effect and simple operation. Mercury in the aquatic ecosystem and its bioaccumulation as methylmercury at higher trophic levels are strongly influenced by the uptake of bioavailable forms of mercury by bacteria enhanced levels of mercury have since been found in fish (Nsikak et al., 2007). Mercury has the potential to bioaccumulate in food chains; the representative selection of an indicator species for a specified ecosystem appears to be a crucial step for reliable interpretation, particularly in long-term studies (Dusek, 2005). Increasing accumulation of mercury in tissues over the lifetime of examined fish can be regarded as an indication of contamination (Rincon et al., 1993; Niimi and Kissoon, 1994; Mueller and Serdar, 2002) and age-related changes then represent a crucial variability component in biomonitoring studies. The accumulation of mercury in the tissues of Clarias batrachus followed the order: Brain > Gill > Liver > Kidney > Muscle. As per the observations made, the accumulation of mercury occurs considerably on 28th day of exposure and significant accumulation takes place in the brain (Table 3 and Figure 1). A possible explanation could be that mercury has a high affinity for the sulfhydryl methyl group compound (Carty and Malone, 1979). Takeuchi (1982) suggested that methylmercury affects the nerve cells during the intermediate or late period of animal fetal life. The present study showed a pronounced change in the brain than in liver and kidney on the 28th day of exposure to mercury. Highest accumulation of mercury in the brain was observed when compared to the liver and kidney. This is because the high affinity of the neurosecretory cells of brain and its strong binding affinity towards mercury. Mercury can easily cross over the blood-brain-barrier system (Smith et al., 1987). Nsikak (2007) indicated in his finding that the accumulation of mercury was significantly higher in liver tissues of Pomadasys jubelini and Oreochromis nilotica. The present observation determined a low molecular bioaccumulation of mercury in the kidneys on the 28th day of exposure to the toxicant. This could be attributed to the low activity and functioning of the kidney in the C. batrachus. The slow blood flow into the renal tissue may lead to less accumulation of mercury in the kidney of the fish (Spitzer, 1985). At the lowest mercury concentration, the metal content was similar in gills, liver and kidneys and they were all statistically different from muscle (Antonia et al., 2003). Romeo et al. (1999) showed that mercury concentrations in edible muscles of pelagic fish species are lower than those of benthic fish species. It is generally accepted that muscle is not an organ in which metals accumulate. Similar results were reported from a number of fish species showing that muscle is not an active tissue in accumulating heavy metals (Karadede and unlu, 2000; Kargin and Erdem, 1991). Chromium is dangerous as it can accumulate in many organisms. The hexavalent chromium behaves toxicologically in a manner quite different from most heavy metal because hexavalent chromium can readily penetrate gill membranes passively and concentrate at high levels in various organs and tissues and can manifest its toxic action internally as well as on the gill surface (Buhler et al. 1977). In the present study the effects of sublethal concentration of chromium on the freshwater fish C. batrachus has been investigated to elucidate the persistence of chromium induced effects during chronic long term exposure. Maximum bioaccumulation was observed in the gill followed by liver, kidney, muscle and brain after 28 days of exposure to chromium (Table 1 and Figure 1). The gills generally showed highest metal concentrations, due to their intimate contact with the environment and their importance as effectors of ionic and osmotic regulation. The degree of chromium bioaccumulation in tissues suggests that the gills take up chromium more readily. Increased bioaccumulation in the gills may be due to the constant and increased ventilatory movements of the operculum under the influence of the xenobiotics. The protective mucous plug inside the opercular chamber is quite often discharged into the medium. Such discharges of mucous plug might make the gills a more vulnerable site for accumulation (Paul and Banerjee 1997). The accumulation of chromium in gill tissue is usually associated with structural damage to the gill epithelium as well as impaired respiratory and osmoregulatory function. These effects have often been cited as the acute mechanism of metal toxicity (Burton et al., 1972). Liver is the tissue with the second highest chromium accumulation. The liver, in its role as a storage and detoxification organ, can also accumulate high levels of metals (Nussey et al., 2000). It is suggested that in the liver chromium is stored and linked to proteins and smaller peptides such as glutathione (Gauglhofer and Bianchi, 1991). According to Heath, (1987) fish excrete chromium via their feces, as shown by high levels in bile during and after the ingestion of contaminated food or contaminated water. A higher concentration of chromium was mostly recorded in the gills followed by the liver. Muscles and skin accumulated much less metal concentrations (Nussey et al., 2000). The concentrations of chromium found in the gills, liver and muscle in this study also supported by various other study (Wepener, 1997). In the present study, the lowest chromium concentrations were mainly found in the muscles. This coincides favorably with the results from other study (; Wepener, 1997). The levels of chromium accumulations in the various organs is as follows Gills > Liver > Kidney > Brain > muscle. These observations agree with results obtained in similar study by (Avenant-Oldewag and Marx 2000) for Clarias gariepinus. The present findings are in perfect harmony with the above results. Thus the transformation, mobilization transport and bioaccumulation of chromium are of fundamental environmental significance.
CONCLUSION
In this study, it was clearly shown that the mercury and chromium exposure is having a significant impact on the brain and gills of the C. batrachus. Knowledge of these 69 International Journal of Current Research and Review www.ijcrr.com Vol. 03 issue 05 May 2011 outputs made a possibility to give a better description of the variation and the pattern of metal accumulation in the various organs of C. batrachus. The scientific data discussed in this study provide a basis for understanding the potential impact, as well as for advancing our knowledge of the ecotoxicology and risk assessment of mercury and chromium.
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2. Antonia CE, Roberta G, Maria IT, Ambrosius JMD Luciana M. Antioxidant responses and bioaccumulation in Ictalurus melas under mercury exposure. Ecotoxic and Environ Saf, 2003; 55: 162–167.
3. APHA. Standard Methods for the Examination of water and wastewater, 19th edition, American Public Health Association, Washington DC. 1995.
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6. Carty AJ, Malone SF. The chemistry of mercury in biological systems. In: The biogeochemistry of mercury in the environment. Nrigau, J.O. (editors.), Elsevier/North Holland Biomedical Press, Amsterdam.1979; p. 433 - 379.
7. Cervantes C, Campos Garcia J, Devars S, Gutierrez-Corona F, Loza-Tavera H, Torres-Guzman JC, Monreno Sanchez, R. Interactions of chromium with microorganisms and plants. FEMS Microbiol Rev., 2001; 25: 335–47.
8. Debnath Surajit. Traditional Consumption of Magur (Clarias batrachus) an Air Breathing Catfish among the Population of North Eastern India is Rationalized by Its Blood Lipid Parameters CHEMFERENCE, Annual Research Symposium, IIT Madras 22 - 23rd August, 2009. Available at SSRN: http://ssrn.com/abstract=1401145.
9. Dusek L, Svobodova Z, Janoušková D, Vykusová B, Jarkovský J, Šmíd R and Pavliš P. Bioaccumulation of mercury in muscle tissue of fish in the Elbe River (Czech Republic): multispecies monitoring study 1991–1996. Ecotoxi and Environl Safe, 2005; 61:256–267.
10. Farhana, Zahir., Shamim, J. Rizwi., Soghra, K. Haqb, Rizwan H. Khanb. Low dose mercury toxicity and human health. Envirol Toxico and Pharma 2005; 20: 351–360.
11. Farombi EO, Adelowo OA, Ajimoko YR. Biomarkers of oxidative stress and heavy metal levels as indicators of environmental pollution in African Cat fish Clarias gariepinus from Nigeria Ogun river. Int J Environ Res Public Health 2007;. 4 (2), 158-165.
12. Ferard JF, Jouany JM, Truhaut R, and Vasseur P. Accumulation of cadmium in a freshwater food chain experimental model. Ecotoxico Environ Safe, 1983;7: 43-52.
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14. Finney DJ. Probit analysis third edition Cambridge University Press, London and New York. 1971.
15. Francisco J, Picado Pavón. Mercury in the environment and the gold mining activity in the St Domingo district, 71 International Journal of Current Research and Review www.ijcrr.com Vol. 03 issue 05 May 2011 Chontales-Nicaragua. Introductory paper no. 2004; 157.
16. Gauglhofer J, Bianchi V.Chromium. In: Merian E (edited.) Metals and their compounds in the environment. Occurrence, analysis and biological relevance. VCH Publishers Inc New York, USA.1991. P 853-878.
17. Goyer RA. Toxic effects of metals. In: Amdur MO, Doull J, and Waarren, CD, Casarett and Doull‘s (edited.) toxicology. The basic science of poisons. Pergamon Press.1992 p 623 - 680.
18. Hayat S, Javed M, Razzaq S. Growth performance of metal stressed major carps viz. Catla catla, Labeo rohita and Cirrhina mrigala reared under semiintensive culture system. Pak Vet J 2007; 7: 8-12.
19. Heath AG, Water Pollution and Fish Physiology. CRC Press Inc, Boca Ranton, Florida, USA 1987; p.245. 20. Kamaruzzaman BY, Akbar B, Jalal KCA, Shahbudin S. Accumulation of metals in the gills of Tilapia ngerlings (Oreochromis niloticus) from in vitro toxicology study. J Fish Aquat Sci 2010; 5: 503-509.
21. Karadede H, Unlu E. Concentrations of some heavy metals in water, sediment and fish species from the Atatürk dam lake (Euphrates), Turkey. Chemosphere 2000; 41: 1371-1376.
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Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-524135EnglishN-0001November30HealthcareCALIBRATION CURVE METHOD DEVELOPMENT FOR ANALYSIS OF TENATOPRAZOLE
English7377Sumit M. DeshmukhEnglish Hemlata M. NimjeEnglish Rajesh J. OswalEnglish Rishikesh V. AntreEnglishA simple and sensitive UV spectrophotometric method has developed for quantitative estimation
of Tenatoprazole of pure drug. Tenatoprazole is antacid. Chemically it is (RS)-3-Methoxy-8-[(4-
methoxy-3,5-dimethyl-pyridin-2-yl)methylsulfinyl]-2,7,9 triazabicyclo[4.3.0]nona-2,4,8,10-
tetraene. Spectral absorbance measurements were made on Systronics double beam UV-VIS
Spectrophotometer with 1 cm matched quartz cells. Tenatoprazole was dissolved in distilled
water and absorbance was measured at 314.0 nm. Beer Lambert‘s law was obeyed in the
concentration range of 0-50μg/ml. The method was statistically evaluated for accuracy and
precision.
EnglishUV visible spectroscopy, Tenatoprazole, Calibration curve methodINTRODUCTION
UV light is defined as electromagnetic radiation having a wavelength less than that of visible light (400 nm) and greater than that of X-Rays (100 nm). The unit of wavelength used is a nanometer (nm) equal to 10-9 meters. Ultraviolet (UV) astronomy concerns celestial observations made in the region of the electromagnetic spectrum1,2 that extends from the near-visible to the Xray regime: the near UV, with wavelengths of 3500 to 2000 A0 the far UV (2000-912 A 0 ) and the extreme UV (912-100 A0 ). The main types of instruments in used for measuring the emission or absorptions of radiant energy from substance are called by various names such as Photometers, is the instrument which measures the ratio, or some function of the two, of radiant power of electromagnetic beam. Tenatoprazole is a prodrug of the proton pump inhibitor (PPI) class, which was converted to the active sulfonamide or sulfenic acid by acid in the secretory canaliculus of the stimulated parietal cell of the stomach. This active species binds to luminally accessible cysteines of the gastric H + , K+ -ATPase resulting in disulfide formation and acid secretion inhibition3,4,5.
Structure of Tenatoprazole Drugs which are in solid dosage forms are widely used for the treatment of various diseases & hence analyst needs to develop suitable identification method for analysis. A certain quantity dose of drug was just introduced in the market as tablet dosage for inhibit excess acid secretion. The efficacy of drug is more the same category so to inhibit the adulteration of drug or to increase the efficacy of drug the standard analysis of drug should be known by Pharmacist. Hence in the present research project attempt has been taken to develop simple, accurate, precise, sensitive as well as less time consuming identification method for simultaneous estimation of the drug Tenatoprazole in tablet dosage form in future6 .
Experimental Method7 Calibration curve can be done by Simultaneous equation methods or Vierodt‘s method, Multi-component method of analysis, Derivative Spectrophotometery, Geometric correction method, Absorption factor method, Difference Spectrophotometry, Orthogonal polynomial functional method, Absorbance ratio method & two wavelength/three wavelength method.
Calibration Curve Method
1) Selection of solvent: Distilled water is used as solvent.
2) Study of spectra, selection of maximum wavelength for Tenatoprazole:
I. Preparation of standard stock solution: An accurately weighed quantity, 100mg, of Tenatoprazole was placed in a 100 ml volumetric flask and dissolved in Distilled water. The volume was made up to mark with Distilled water to get concentration of 1000 µg/ml.
II. Study of spectra and selection of maximum wavelength (λ max) The aliquots of standard stock solution of Tenatoprazole was diluted with 100 ml Distilled water to obtain concentration 10µg/ml Solution was taken in 1cm cell and scanned in range 200nm to 400nm.
III. Study. of Beer-Lambert’s law Accurately measured aliquots of standard stock solution ranging from 0.1ml to 4ml were taken in series of 10ml volumetric flask and diluted up to Distilled water the mark with to get Concentration in range of 1-40 µg/ml. The absorbance of each solution was measured at 314.0nm.
RESULTS
DISCUSSION AND CONCLUSION
In distilled water, Tenatoprazole exhibits absorption at 314.0 nm. The linearity was observed in concentration range of 0-40 µg/ml. The amount of Tenatoprazole estimated by proposed method was in good agreement with the label claim. The low % RSD value indicates that method is accurate. The proposed method is simple, accurate, economical and be used in routine analysis of Tenatoprazole from tablet formulation.
ACKNOWLEDGMENT
The authors are thankful to Emcure Pharmaceutical Industry, Bhosari, Pune for providing the pure drug samples and Mr. Pravin Chavan for kind cooperation. Authors are also thankful to Prof. T. J. Sawant, founder secretary Jaywant Shikshan Prasarak Mandal`s for providing laboratory facilities.
Englishhttp://ijcrr.com/abstract.php?article_id=2177http://ijcrr.com/article_html.php?did=21771. The United State‘s Pharmacopoeia 29/National formulary 24, The united state pharmacopoeial convention, Rockville, 2006. Page no. 3050-3052.
2. Friedel, Robert, and Paul Israel. 1987. Edison's electric light: biography of an invention. New Brunswick, New Jersey: 77 International Journal of Current Research and Review www.ijcrr.com Vol. 03 issue 05 May 2011 Rutgers University Press. Page no. 115- 117
3. Joshi M, Nikalje AP, Shahed M, Dehghan M, HPTLC method for the simultaneous estimation of Tenatoprazole, Indian Journal of Pharmaceutical Sciences, 71, 1, 2009, 95- 97.
4. Ashithosh Kar Pharmaceutical Drug Analysis New Age International Publishers,Delhi,2nd ed2005,Page no:303-306
5. Gurdeep R.Chatwal and Aham K.Anand Instrumental mehods of chemical analysis Himalaya publishing house, Mumbai,5thed. 2008,Page No-2.118-2.29
6. Conners K. A., Textbook of Pharmaceutical Analysis, 3 rd Edition, A Wiley-Intersciences Publication, 1999,Page no: 616-622.
7. Beckette A.H. Stenlake J.K. Practical Pharmaceutical Chemistry, Fourth edition, CBS publisher‘s and Distributor‘s, New Delhi, 1997, Page no.275-336.
Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-524135EnglishN-0001November30General SciencesERP SYSTEMS IMPLEMENTATION SUCCESS: A STUDY ON IRANIAN ORGANIZATIONS
English78100Shahin DezdarEnglish Sulaiman AininEnglishThis study proposes a framework that examines factors that influence the successful
implementation of ERP systems. Six critical success factors (enterprise wide communication,
business process reengineering, project management, team composition and competence, ERP
system quality and ERP vendor support) were identified and used to collect empirical evidence.
In addition, organizational culture was examined to determine whether it has any moderating
effect on the six variables in relation to ERP implementation success. A survey questionnaire was
distributed to organizations with ERP. The targeted respondents were ERP users within the
companies. A total of 384 responses were used for analysis. The data obtained was analysed
using the Structural Equation Modelling. The results indicated that that ERP implementation
success is influenced by enterprise wide communication, project management, team composition
and competence, ERP system quality and ERP vendor support. It was also found that
organizational culture moderates the relationships between enterprise-wide communication,
project management, team composition and competence, ERP system quality, ERP vendor
support and success of ERP implementation.
EnglishOrganizational culture, ERP, critical success factor, Iran1. INTRODUCTION
Enterprise Resource Planning (ERP) systems can potentially allow a company to manage its business better with potential benefits of improved process flow, better data analysis, higher quality data for decision-making, reduced inventories, improved coordination throughout the supply chain, and better customer service. In spite of the many benefits the adoption of ERP systems has not been without problems. A report on ERP implementation projects reveals that on average, 178% are over budget, took 2.5 times as long as projected and delivered only 30% of the promised benefit (Zhang et al. 2005). Moreover, ERP is arguably the single biggest information technology investment an organization can make. Given the high expenses and low success rate, the causes of these problems or failures need to be understood and solutions leading to success need to be found (Dezdar and Ainin 2011). There are several studies that have addressed the concern above. However, many of the studies focus on specific variables. For example, Holland and Light (1999) focused on strategic factors that span the whole project and tactical factors that can be applied to particular parts of the project while Esteves-Sousa and Pastor-Collado (2000) focussed on strategic, tactical, organizational and technical aspect. This study tries to fill the gap by introducing a framework that combines several variables to give a better understanding of the factors that may affect ERP implementation success.
Moreover most of the studies were conducted in developed countries whereas developing countries may face different challenges in ERP implementation from those faced by developed countries (Chien et al. 2007). In addition, studies undertaken in developed countries may not be applicable in other context (Pairat and Jungthirapanich 2005). Ngai et al. (2008) argued that critical success factors (CSFs) may vary depending on the country in which an ERP implementation is carried out. While many developing countries are now adopting ERP, there has not been much research on the success or failure of its implementation in these regions/countries (Ngai et al. 2008; Sawah et al 2008). Thus, this study focuses on a developing country which is under researched i.e. Iran. Yeganeh and Su (2008) claimed that Iran is a country in the MiddleEast region which has also many commonalities with its neighbouring Muslim countries. The Iranian culture is unique as it consist two dissimilar vectors i.e. Islamism and nationalism. The Islamist facet is comparatively young and dates back to the 7th century. On the other hand, the nationalist feature of Iranian culture is connected to its Zoroastrianism heritage and Ancient Persian civilization which date back to 3000-2000BC but which are still common in diverse aspects of Iranian society like Persian literature, New Year Festivals (Nowrooz) and the Calendar. Following the gaps discussed above, this study aims to identify the critical success factors that influence ERP implementation success in Iranian companies. In addition, it will also analyse the moderating effect of organizational culture on the variables in the model in relation to ERP implementation success. In the following sections, the related literature is reviewed. Then, research framework and hypotheses are presented followed by the research methodology chosen to conduct the study. Next, data collection and analysis are described and findings are discussed. Finally, conclusions and implications for future research are highlighted.
2. ERP Implementation Success
In systems, success takes on special urge2. ERP Implementation Successncy since the cost and risk of these valuable technology investment opponents the possible payoffs. These modern IS characteristics suggest that existing models of IS success may not be entirely appropriate for measuring enterprise system success (Ifinedo 2007). There were two main streams in the literature for measuring ERP success. Some prior studies used objective organizational measures, such as company cost and profits figures as measurement items for ERP success. But many researchers utilized self-reported 80 International Journal of Current Research and Review www.ijcrr.com Vol. 03 issue 05 May 2011 subjective ERP success measures. Although it may be more desirable to measure system success in terms of monetary costs and benefits, such measures are often not possible due to the difficulty of quantifying intangible system impacts and also isolating the ERP effect from numerous intervening environmental variables that may influence organizational performance (Chien and Tsaur 2007). There have been prior researches that employed diverse subjective or nonfinancial criteria to measure ERP success. Some of the researchers have employed one, two or more dimensions of DeLone and McLean (1992; 2003) success models (Chien and Tsaur 2007; Ifinedo 2007). Other researchers have utilized ?Technology Acceptance Model (TAM)‘ (Bueno and Salmeron 2008; Shih 2006). A number of researchers have applied ?Project Management‘ measures such as time and budget (Peslak 2006). Several researches have utilized ?User Satisfaction‘ as an individual measure of ERP implementation success (Chen and Liu 2008; Holsapple et al. 2005). In addition, many researchers have used a combination of measures in their research (Bradley 2008; Chien et al. 2007). A key question in examining the deployment of ERP systems is centered on determining the critical success factors that lie behind a successful implementation. ERP system implementation is a process of great complexity, with a great many conditions and factors potentially influencing the implementation. These factors could have a positive effect on the outcome of ERP project, while their absence could generate problems during implementation. Many studies have been conducted during the recent years to identify the factors affecting the ERP implementation success and failure. The CSF method is an attractive method for researchers and managers because it facilitates the identification and prioritization of critical factors that will possibly affect successful ERP implementation (Dezdar and Sulaiman 2009). Since 1999, a lot of IS researchers have been increasingly utilizing CSFs to study ERP system implementations. In ERP system implementation, CSFs could be recognized as the few key areas where things must go right for the implementation to succeed (Finney and Corbett 2007). The ERP literature varies regarding what factors are required for successful implementation (Zhang et al. 2005). Many authors have identified a variety of factors that can be considered to be critical to the success of an ERP implementation. For example, Somers and Nelson (2001) recognized 22 critical success factors assessed them across phases of 110 ERP implementation cases. Al-Mashari et al. (2003) presented a categorization of ERP critical factors where 12 factors were divided into three dimensions related to the stages of ERP project. Nah et al. (2003) performed a survey of the Chief Information Officers (CIOs) of Fortune 1000 companies to gain some understanding of the CIOs‘ views of the importance of each of the 11 criteria in determining the success in the implementation of an ERP system. Somers and Nelson (2004) divided the 22 CSFs to two parts as ?key players‘ and ?key activities‘. Nah and Delgado (2006) reviewed the literature on CSFs in ERP implementation to identify an extensive list of factors and then structured them into 7 main categories. Sedera and Dey (2006) combined the works of prior researchers and proposed 11 CSFs. Brown and He (2007), based on the importance and/or frequency of a critical factor in the source literature, 81 International Journal of Current Research and Review www.ijcrr.com Vol. 03 issue 05 May 2011 identified 13 factors as critical for ERP implementation.
3. Research Framework and Hypotheses Development
The research framework of this study was developed based on the content analysis of literature followed by interviews with six experts in the field of ERP implementation in Iran. The purpose of literature review is to identify and highlight the important variables, and to document the significant findings from earlier research that will serve the foundation on which the conceptual or theoretical framework for the current investigation can be based and the hypotheses developed (Cavana et al. 2001). The content analysis (Dezdar and Sulaiman 2009) identified 17 CSFs (independent variables) and 11 success measures (dependent variables). It must be highlighted however that most of the research were conducted in developed countries and developing countries may face different challenges from those faced by developed countries (Chien et al. 2007). Ngai et al. (2008) argued that CSFs may vary depending on the country in which an implementation is carried out. So, studies undertaken in developed countries may not be applicable in other context (Chien et al. 2007). It is, thus, difficult to conclude whether all these CSFs are relevant to companies in a dissimilar context of this study (Iran). Therefore, a set of interviews was conducted with six key persons involved in ERP implementation projects in Iran. The interviewees comprised of ERP consultants, vendors‘ representatives and implementation project managers. The interviews were conducted in person on a one to one basis. The interviewees were given a list of 17 CSFs and 11 ERP success measures (identified earlier) and were asked to rank it according to their relevance to the implementation process in the context of Iran. Finally, the expert judgments were analysed. From the list it was concluded that not all the CSF and success measures are applicable in the Iranian context. In addition, the interviewees also pointed out that several of the factors implies/carry the same meaning. Subsequently, the following research framework was developed Figure (1)
3.1. Enterprise-Wide Communication (EWC
) Communication across the different levels and functions of an organization is necessary for success in ERP implementation (Akkermans and Helden 2002). Communication is crucial as it helps to minimize the user resistance (Somers and Nelson 2004). Effective communication of requirements, direction, mission, plan, user input, feedback and changes is critical to all stages to ERP implementation (Nah et al. 2003). Hence, the following hypothesis was developed.
H1: Enterprise-wide communication is positively related with ERP implementation success. 3.2. Business Process Reengineering (BPR) In the process of configuring the ERP system, a large amount of reengineering should occur iteratively to take advantage of the best practices offered by the system. Business process should change to follow to the requirement of the software. The ERP software should have minimal changes as it is often a sign of success and will lead to lower costs and shorter implementation timeframe (Sedera and Dey 2006). Consequently, the following hypothesis was defined: H2: Business processes reengineering is positively related with ERP implementation success.
3.3. Project management (PRM) The combination of hardware and software and the numerous organizational, human and political issues make many ERP projects massive and naturally complex, requiring strong project management skills (Somers and Nelson 2004). Consequently, a strong project management team is critical for ERP implementation activities to avoid schedule and cost overruns (Sedera and Dey 2006). So, the following hypothesis was developed. H3: Effective project management is positively related with ERP implementation success.
3.4. Team Composition and Competence An ERP project requires the effort and cooperation of technical and business experts as well as end-users. Hence, teamwork composition among the implementer, vendor, and consultants are emphasized in ERP implementation (Nah and Delgado 2006). Also, the success of ERP has often been linked to the presence of a champion, who performs the crucial functions of transformational leadership, facilitation, and marketing the project to the users (Wu and Wang 2007). Therefore, the following hypothesis was developed: H4: ERP team composition and competence is positively related with ERP implementation success.
3.5. ERP System Quality (SYQ) ERP system quality is measured in terms of flexibility, reliability, and accessibility (Fan and Fang 2006). Nelson et al. (2005) suggested five dimensions to measure system quality including accessibility, reliability, flexibility, response time, and integration. It has been mentioned that system quality affects the implementation success of any ERP system (Zhang et al. 2005). As a result, the following hypothesis was formulated: H5: Quality of ERP system is positively related with ERP implementation success.
3.6. ERP Vendor Support (VES) The need for vendor‘s support in ERP implementation is stronger than in other IS projects because ERP implementation project requires a wide range of skills and technical implementation knowledge. All users must be trained to take full advantage of the system‘s capabilities to ensure successful implementation (Al-Mashari and Al-Mudimigh 2003). Consequently, vendor support, in the form of technical assistance, emergency maintenance, updates, and special user training, is a vital factor with ERP software implementation (Somers and Nelson 2004). Hence, the following hypothesis was developed: H6: ERP vendor support is positively related with ERP implementation success.]
3.7. Organizational Culture (ORC) Seddon et al. (2003) stated that when two companies implement the exact same ERP package, the results sometimes are different as they practice different cultures. Organizational culture has been utilized as an independent variable in prior ERP implementation success researches. Three researches examined the moderating effect of organization culture on the relationship between critical factors and ERP implementation success, i.e. Nah et al. (2007) and Ramayah et al. (2007) in Malaysia, and Hong and Kim (2002) in South Korea. Based on the findings of these researches, ?organizational culture‘ was put as a moderator variable in this study which moderates the relationship between CSFs and ERP implementation success. Hence the following hypotheses were developed:
H7-H12: Organizational culture moderates the relationship between critical factors (EWC, BPR, PRM, TCC, SYQ and VES) and the success of ERP implementation.
4. RESEARCH METHODOLOGY 4.1. Research Design As mentioned earlier the aim of this research is to examine factors that effect the implementation of ERP success in Iran. The population for the study is Iranian companies that adopt ERP. Since there was no single source which complied this database, the websites of international ERP vendors, local IS vendors, governmental and non-governmental organizations in charge of IT and Tehran Stock Exchange were examined and reviewed. Finally, a list of 31 companies was compiled. The organizations were contacted and 25 agreed to participate in the study.
4.2. Instrument Development A survey questionnaire was employed to collect data for this research. Items used in the operationalization of the constructs were adapted from relevant prior research (Bradley 2008; Hofstede 2001; Ifinedo 2007; Nah and Delgado 2006; Nah et al. 2007; Sedera and Dey 2006; Zhang et al. 2005). All question items were measured using a seven-point Likert-type scale with anchors ranging from ?strongly disagree‘ to ?strongly agree‘. The mean of scores over all questions provided the composite score for each variable. The questionnaire consisted of three sections. In section one, a range of demographic data such as age, gender, level of education, ERP usage period, and ERP usage frequency was presented. In section two, 53 items were provided to tap the elements of the constructs. The last section consists of an open-ended question allowing respondents to comment on any aspect they choose. To test the validity of the questionnaire, ?expert judgment validity‘ was carried out. From a review of the literature, researchers in the area were identified and a set of problem statement, research objectives, research questions, research framework and questionnaire was sent to them via e-mails. However only five responded confirming the research framework and questionnaire set. The questionnaire was translated to Persian language using the back-to-back technique to ensure the meanings are the same as the original. To ensure the reliability of the questionnaire, a pilot study was conducted. The questionnaire was distributed to 54 operational managers and 37 completed questionnaires were collected. The data were tested using the SPSS software 16.0 and it was found that all the variables‘ cronbach alpha values were above 0.7 hence the questionnaire was considered to be reliable as suggested by Hair et al. (2006).
4.3 Data Collection As mentioned earlier the companies were contacted and were required to identify a person to liaise with the researcher. The liaison person then was required to distribute the questionnaires to all their operational/functional/unit managers who use ERP systems. After constant reminder, 411 completed questionnaires were collected and 384 were used for analysis as the remaining was incomplete.
5. DATA ANALYSIS AND FINDINGS The first part of analysis involves the use of descriptive statistics showing the frequencies and percentages of the demographic variables. The second part of the analysis examines the effect of CSFs on 84 International Journal of Current Research and Review www.ijcrr.com Vol. 03 issue 05 May 2011 ERP implementation success, using Structural Equation Modeling (SEM). The analysis was carried out in accordance with a two-step methodology proposed by Hair et al. (2006). According to this procedure, after the model has been modified to create the best measurement model, the structural equation model can be analyzed. The third part examines the moderating effect of organizational culture in the proposed model.
5.1. Sample Characteristics The characteristics of respondents are presented in Table (1). As can be seen, there were more male respondents, more than two-thirds of respondents were between 31- 50 years old. More than three-fourths of the respondents held university degree and had more than 6 years of experiences in their companies. The profile of the respondents illustrate that the majority of respondents were involved fully or partially in the ERP implementation project. The ERP usage profile of the respondents demonstrates that one third of the respondents used Finance module of ERP and module of Logistics was employed by one fourth of respondents. The data shows that the majority of respondents used ERP systems for at least 2 years. With respect to ERP usage frequency, more than two-thirds of respondents utilized ERP systems at least once a day. These records express that the respondents were well experienced and highly educated. Moreover, the respondents were familiar to the business and company‘s processes and ERP implementation projects as well. In addition, they were familiar with ERP systems‘ capabilities and outcomes. As a result, the respondents were the best informant people to answer the survey.
5.2. Measurement Model Confirmatory factor analysis (CFA) was conducted using AMOS 16.0. The overall effectiveness of the measurement model was examined using four common model fit measures: normed χ2, goodness-of-fit index (GFI), comparative fit index (CFI), and root mean square error of approximation (RMSEA). The measurement model in the CFA was revised by removing items that had large standardized residuals with other items, one at a time. After dropping four items (EWC6, TCC6, SUC5 and SUC10) the measurement model exhibited overall good fit. The normed χ2 was 2.656, which was below the maximum desired cutoff of 3.0. RMSEA was 0.066, indicating a good fit, below the maximum desired cut-off of 0.08. Also CFI=0.916 was above the recommended threshold of 0.90., suggesting that the measurement model fit the data adequately (Hair et al. 2006). Further analysis was conducted to assess the psychometric properties of the scales. Convergent validity was assessed using three measures: factor loading, composite construct reliability, and average variance extracted. The outcomes of convergent validity test are offered in Table (2). First, the entire factor loadings of the items in the measurement model were greater than 0.70 and each item loaded significantly (p < 0.01 in all cases) on its underlying construct. Second, the composite construct reliabilities were within the commonly accepted range greater than 0.70. Finally, the average variances extracted were all above the recommended level of 0.50. Therefore, all constructs had adequate convergent validity as stated by Hair et al. (2006). To confirm discriminant validity, the average variance shared between the construct and its indicators should be larger than the variance shared between the construct and other constructs. The outcomes of convergent validity test are offered in Table (3). As shown in Table (3), all constructs share more variances with their indicators than with other constructs.
5.3. Structural Model This stage of the SEM process involved testing the structural model prior to testing the hypotheses. The proposed structural model (Figure 2) was examined using SEM package AMOS 16.0. Based on the results of the SEM fit indices, the proposed model presented an acceptable fit. The RMSEA=0.063 was lower than the accepted cut off of 0.08. Also CFI=0.919 was greater than the recommended level of 0.90. Overall, the hypothesized structural model provided a good fit for the data.
5.4. Hypotheses Testing The purpose of this study is to investigate the impact of six critical success factors on ERP implementation success. The hypothesized relationships are now ready to be tested based on the structural model specified previously. The six hypotheses are represented by the six relationships in the model. Hypothesis (1) is represented by the relationship EWC → SUC; Hypothesis (2) is represented by the relationship BPR → SUC; Hypothesis (3) is represented by the relationship PRM → SUC; Hypothesis (4) is represented by the relationship TCC → SUC; Hypothesis (5) is represented by the relationship SYQ → SUC; Hypothesis (6) is represented by the relationship VES → SUC. In addition, this study was designed to incorporate the interacting effects or moderating roles of organizational culture to provide more insight into ERP implementation projects. So, there are also six hypotheses which examine the moderating effect of organizational culture on the relationships between the six critical success factors and ERP implementation success. Hypothesis (7) is represented by the relationship EWC*ORC → SUC; Hypothesis (8) is represented by the relationship BPR*ORC → SUC; Hypothesis (9) is represented by the relationship PRM*ORC → SUC; Hypothesis (10) is represented by the relationship TCC*ORC → SUC; Hypothesis (11) is represented by the relationship SYQ*ORC → SUC; Hypothesis (12) is represented by the relationship VES*ORC → SUC. The standardized path coefficients and tvalues of all the hypothesized relationships of the research model were presented in Table (4). According to Hair et al. (2006), the standardized coefficient illustrates the consequential change in an endogenous variable from a unit change in an exogenous variable, with all other exogenous variables being held constant. In this method, their comparative contributions can be recognized much more clearly. The sign of the coefficient signifies that the two variables are moving in similar or dissimilar directions. The t-value indicates whether the corresponding path coefficient is significantly different from zero. Coefficients with t-values of between 2.00 and 2.00 show they are not significantly different from zero at the 5% significance level. It means that there is a high probability of obtaining a relationship of this magnitude simply by sampling error. In addition, the SEM path analysis results are shown in Figure (3). The significant relationships (paths) are illustrated in bold lines, while insignificant relationships are shown by dashed line in this Figure. The first number in parenthesis shows the standardized coefficient and second number indicates the t-value of each hypothesized relationship. To sum up, out of the 12 hypothesized relationships, 10 were found to be significantly supported. Hypotheses 1, 3, 4, 5, 6, 7, 9, 10, 11 and 12 all had a t-value of greater than 1.96, indicating the relationships were significant at the 0.05 level. The t-value for Hypothesis 2 and Hypothesis 8 were -1.243 and -1.448 respectively, which were not significant at the 0.05 level. Therefore, all research hypotheses except Hypotheses (2) and (8) were supported by the AMOS structural modeling results. The R-square value of the research model is 0.543 when no moderating effect is considered. However, the R-square value increases to 0.655 when organizational culture is taken into account as the interaction term. The model with organizational culture as a moderator accounts for 65.5% of the variance of ERP implementation success. The increased Rsquare recommends that organizational culture is a moderator in the proposed research model. For estimating the effect size of organizational culture, the guidelines provided by Cohen (1988) were employed. In sum, the effect size of 0.371 or above is considered large, the effect size between 0.100 and 0.371 is considered medium, and the effect size of 0.1 or below is considered small. So, the result of the effect size (ƒ2) in this study indicated that the organizational culture‘s interacting effect is medium, i.e. ƒ2 is 0.254.
6. DISCUSSIONS
The findings of this study support the proposed hypothesis (H1) that there is positive relationship between EWC and SUC. This finding is consistent with outcomes of studies conducted in western countries (Kim et al. 2005) and developing countries (Al-Mashari et al. 2006; Chien et al. 2007; Colmenares 2004; Garcia-Sanchez and Perez-Bernal 2007; Nah et al. 2007; Ramayah et al. 2007). Once organizations make the decision to implement ERP systems, they have to use communication to explain and justify their actions. What is important is how that justification is translated to lower level employees so that they feel motivated to go along with the implementation and not resist the changes that will occur. The company‘s top management should inform all employees of their ERP plans and of the benefits that ERP will bring to the company. BPR was hypothesized (H2) to be positively correlated with SUC. However, the hypothesized relationship was not supported. This finding highlights the outcomes of majority of studies conducted in developing nations (Kamhawi 2007; Ramirez and Garcia 2005; Zhang et al. 2003). A number of studies have pointed out that the popular ERP packages developed by Western countries may not fit the requirements of other organizations due to different business practices, and legal and government requirements (Ngai et al. 2008). Western ERP packages are implemented in other countries; it is likely that the ERP‘s underlying business logic conflict with the local business logic, causing misfits which negatively affect the ERP implementation outcomes (Davison 2002). Many ERP adopting organizations in Asia have experienced misfit problems (Xue et al. 2005). Likewise, companies in Iran may have requirements such as Persian user interfaces, report formats, and many rules and regulations required by the Iranian government, which Western packages fail to satisfy. As a result, Iranian ERP adopters had to rely on ERP customization more than BPR practices to overcome the misfit problems. The results of this study support the proposed hypothesis (H3) that there is positive relationship between PRM and SUC. This result not only supports the findings of previous researches in western countries (Bradley 2008), but also confirm the results of researches conducted in developing countries (Al-Mashari et al. 2006; Colmenares 2004; Garcia-Sanchez and Perez-Bernal 2007; Kamhawi 2007; Nah et al. 2007; Sawah et al. 2008; Zhang et al. 2003). Organizations should have an effective project management strategy to control the implementation process to avoid overrun of budget and ensuring implementation on schedule (Zhang et al. 2005). Moreover, the scope of the project should be clearly established, managed, and controlled. Proposed changes should be evaluated against business benefits, and scope expansion requests should be assessed in terms of the additional time and cost of proposed changes. Milestones and targets need to be actively monitored to track the progress of an ERP project (Somers and Nelson 2004). The findings of this study support the proposed hypothesis (H4) that there is positive relationship between TCC and SUC. The results of previous researches in developed nations (Bradley 2008; Loh and Koh 2004; Peslak 2006) and developing countries (Al-Mashari et al. 2006; Chien et al. 2007; Colmenares 2004; Garcia-Sanchez and Perez-Bernal 2007; Ramayah et al. 2007) prove the finding of current study. An ERP project demands the effort and cooperation of technical and business experts as well as end-users. It is necessary to form a skillbalanced project team having internal and external experts, managerial competencies, deep knowledge of the processes, and IT skills. The team also should be provided with clear role definitions (Nah et al. 2003). Moreover, the key member of the project team must be empowered to make decision (Ngai et al. 2008). The findings of this study support the proposed hypothesis (H5) that there is positive relationship between SYQ and SUC. The study affirms that the ERP implementation success tends to be rated highly when a high-quality system is implemented. The finding of current study is consistent with results of studies conducted in developing countries (Chen and Liu 2008; Fan and Fang 2006; Kamhawi 2007; Zhang et al. 2005). The findings suggest that it is necessary for ERP implementation managers to spend time and effort to make sure that users are satisfied with system reliability, functionality, flexibility and user friendliness, as these are identified as the most important factors that contribute to ERP success when implementing ERP systems. These qualities can be confirmed through ERP software selection and through ERP implementation, including system configuration. The findings of this study support the proposed hypothesis (H6) that there is positive relationship between VES and SUC. This finding is consistent with outcomes of studies conducted in developing countries (Colmenares 2004; Dowlatshahi 2005; Ramayah et al. 2007; Zhang et al. 2003). Companies intending to acquire ERP systems should take a close look at the ERP providers. Factors that should be taken into account when choosing a provider should include the implementation support they offer and the competence of the installers. It is important for the vendor‘s staffs to be knowledgeable in both business processes and ERP system functions. Also, the vendor employees should possess good interpersonal skills and be able to work with user in ERP adopting organization (AlMashari and Al-Mudimigh 2003). The findings of this study support the hypothesis (H7) which states ORC moderate the relationship between EWC and SUC. This is in line with finding of two prior researches conducted in another developing country (Nah et al 2007; Ramayah et al. 2007). An open and supportive organizational culture promotes increased interaction and improved communication, which help to facilitate communication of new and complex concepts of ERP systems to the end-users. Since the complexity of an ERP system will require almost all company personnel to learn new tools and new ways of working, organizational culture can facilitate the learning process involved in successful ERP implementation (Nah et al 2007).
Hypothesis (H8) cannot be supported by this research, which states ORC moderate the relationship between BPR and SUC. No prior researchers have investigated this relationship so far. Since ERP systems require considerable changes in the organization it is common with resistance, confusion and errors within the implementing organization. So, change management activities are important in the all stages of ERP implementation (Somers and Nelson 2004). The proximity of an organization towards a learning state would, in theory, greatly facilitate the process of change. Organizational members must collaborate and share their knowledge as a team to successfully bring about the changes in the business required to realize long-term ERP benefits (Nah et al. 2007).
The results of this research confirm the hypothesis (H9) that declares ORC moderate the relationship between PRM and SUC. This finding is in harmony with finding of the only prior research in another developing country (Nah et al 2007). ERP project leader faced with the challenge of managing an ERP project this massive typically face tight deadlines and a near-impossible means of disseminating all the required training to end-users. Furthermore, the leaders of the project team need to clearly specify responsibilities, establish and control project scope, evaluate any proposed change, assess scope expansion requests, define and set project milestones, enforce timeliness of the project, and coordinate project activities across all affected parties. An open and learning organizational culture also facilitates the execution of a project management program, which increases the chances of success in ERP implementation. The findings of present study support the hypothesis (H10) that asserts ORC moderates the relationship between TCC and SUC. This finding is in accord with findings of prior research in another developing country (Ramayah et al. 2007). ERP implementation teams are by necessity cross-functional, as the new system brings together and integrates the various functions within an organization. In order to derive the best benefits from the ERP system, the cross-functional teams working on the project should not only be able to work well together, but also understand and appreciate the different strengths and skills that each member brings to the teams. Closed system culture of organization is more prone to come across difficulties in facilitating teamwork and coordination among members of cross-functional teams.\
The findings of this study support the hypotheses (H11) and (H12) which state ORC moderate the relationship between SYQ - SUC and VES - SUC. These are in line with findings of two prior researches conducted in developing countries (Hong and Kim 2002; Ramayah et al. 2007). The cultural diversity between ERP customers and ERP vendors indicates not only organizational culture but also national culture (Krumbholz and Maiden 2001). The national culture differences exist more in values and less in practices, and organizational culture differences reside more in practices and less in values (Hofstede 2001). The problem is that the customer‘s organizational culture clashes with the vendor‘s culture, implicit in the ERP package (Krumbholz and Maiden 2001). To bridge the cultural diversity, the organizations have to choose among changing the organizational culture and business process to fit into the off-the-shelf ERP systems, or customizing the package to smooth alignment of the software functionality to business requirements. As a result, the companies need to consider the cultural diversity among vendors and themselves before they decide which ERP packages to purchase and implement.
7. CONCLUSIONS
This study developed and empirically tested a model for ERP implementation success in the context of a developing country, namely Iran. An attempt was made to identify the critical factors that are likely to influence the successful implementation of ERP systems. Also, a framework for evaluating the ERP implementation project was developed. The proposed model analyzed the relationship between six independent variables, i.e. EWC, BPR, PRM, TCC, SYQ, and VES with SUC as dependent variable. Also, the moderating effect of ORC on the above mentioned relationships was examined. The results of the data analysis showed that five critical factors (EWC, PRM, TCC, SYQ, and VES) out of six had significant relationship with ERP implementation success. In addition, the results illustrated that ORC had moderating effect on the relationship between EWC, PRM, TCC, SYQ, and VES with ERP implementation success.
The findings maybe further explained based on Hofstede (1984) assessment on Iran i.e. it is a collectivistic, high power distance, and uncertainty avoidance society. Iranian has a collectivistic culture whereby they are interested in operating on the basis of individual relationships among persons, rather than on the basis of impersonal associations (Yeganeh and Su 2007). Having a team which is not only competent but also whose composition is varied allows for successful ERP implementation. The high power distance among Iranians has its roots in several features of Iranian history, mythology, religion, politics, and family structure (Dastmalchian et al. 2001). Those in authority openly demonstrate their rank and the subordinates are required to follow the instructions given without much resistance. Thus, through effective enterprise wide communications the ERP implementations within the organizations could be successfully implemented. As Iranians have moderate level of tolerance for uncertainty they would require more information on the ERP systems before implementing them in their organizations. For example, they would find out what and how existing process would change (business process reengineering) and the quality of the ERP system before implementation. This study resulted in important theoretical contributions. First, this study has contributed to academic research by producing the empirical evidence to support the theories of critical success factors and ERP implementation success. This research confirmed that enterprise-wide communication, project management, team composition and competence, ERP system quality and vendor support positively related with ERP system success. Second, this research is the first study to conceptualize a framework that look at the relationship between ERP implementation success, organizational characteristics, ERP project characteristics, ERP innovation characteristics, and organizational culture. Third, organizational culture has been overlooked in prior studies (Zhang et al. 2005). Empirical evidence from this study suggests that organizational culture is an important unique factor which effectively moderates the relationship between some CSFs and ERP system implementation success. Forth, these findings are also important if the context of this research is taken into consideration. No prior researches aimed to study ERP implementation in Iran. This research will thus add to the growing body of knowledge on ERP implementations in developing countries. Fifth, this study developed a research model which could be applied into other Asian, Muslim and developing countries to test its applicability or for those interested in cross cultural issues of ERP implementation.
This research found significant managerial implications. First, Iranian companies and managers could gain an understanding of the complexities inherent in ERP installations to avoid barriers and increase the likelihood of achieving desired results. Second, this study cautions us against assuming that best practices and success factors in developed nations will necessarily apply for developing nations. Before ERP adoption, thorough misfit analysis and resolution plan based on ERP knowledge will help achieve the expected benefits of the ERP systems (Kamhawi 2007). Third, the findings suggest that it is important for ERP adopters to recognize the cultural differences embedded in foreign ERP applications (Wang et al. 2005). Firms planning to adopt ERP systems must ensure that open oriented systems, learning, collaborative, and supportive attitudes are promoted in the organization. Fourth, the outcomes of this study are also useful to ERP vendors and consultants to be familiar with the difficulties of implementing in developing countries and to prepare some strategies to overcome the barriers. Fifth, experiences revealed can be useful to other developing countries with similar cultural, economic and political environments, in the MiddleEast region, Muslim and developing countries.
Several limitations of this study should be highlighted. The first limitation of this study is its generalizability. This study presents the viewpoints of corporations operating in Iran in the region of Middle-East. It is difficult to say whether our findings can be generalized to other regions of the world, because ERP implementation processes have been reported to be influenced by crossnational and cultural factors (Ifinedo 2007). Furthermore, ERP implementation success dimensions were measured using subjective and perceptual measures. This was due to the difficulty in securing the related factual data from the participating organizations. However, a common practice in the literature is highly subjective and this measurement approach was deemed appropriate here (Chien et al. 2007; Nah et al. 2007).
Since few empirical studies have examined the ERP implementation success in developing countries, there are numerous paths for future research and extensions of this study. This research employed subjective measures of ERP implementation success. It is suggested to potential researchers to employ some quantifiable measures and compare their outcomes with findings of our research. In addition, future researches might employ several key CSFs that were deemed important but were not integrated in this study including top management support and commitment, change management program, user training and education, and use of consultant.
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Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-524135EnglishN-0001November30HealthcareACACIA CATECHU WILLD: A PHARMACOLOGICAL REVIEW
English101111Lakshmi TEnglish Geetha R.VEnglish Anitha RoyEnglishOver the past decade, herbal and ayurvedic drugs have become a subject of world importance,
with both medicinal and economical implications. A regular and wide spread use of herbs
throughout the world has increased serious concerns over their quality, safety and efficacy.
Acacia catechu willd (AC). (Family: Fabaceae and subfamily: Mimosoideae) known as Black
cutch has a diverse pharmacological and phytochemical importance. It is a potent medicinal plant
in the traditional Indian medicinal systems. Thus, a proper scientific evidence or assessment has
become the criteria for acceptance of herbal health claims. This review article explores the
traditional knowledge or claims along with pharmacognostical, phytochemical, pharmacological
and future aspects of this plant. Over many centuries humans have been mining the bounties of
nature for discovering new phytoconstituent that have been used for the treatment of number of
diseases; many such treatments are useful even today as modern day medicine. Emerging
evidence also suggests that search is still continuing for harnessing active compounds from nature
in combating human illnesses and it also leads the path to search out new active natural and novel
semisynthetic or synthetic compounds.
EnglishAcacia catechu willd, Herbs ,Pharmacological activity,Phytochemical activity.INTRODUCTION
During the past decade, the indigenous or traditional system has gained importance in the field of medicine. A large number of populations depend on the traditional practitioners, who are dependent on medicinal plants to meet their primary health care needs. Although, modern medicines are available, herbal medicine retained their image for historical and cultural reasons. Since the usage of these herbal medicines has increased, issues and moto regarding their quality, safety and efficacy in industrialized and developing countries are cropped up.1 In order to make sure the safe use of these medicines, a necessary first step is the reviewing the whole plant for its potential as a medicinal plant. Acacia catechu willd (AC) locally known as karungali in Tamil (English name: Black cutch) Family: Fabaceae, first described in Africa by the Swedish botanist Carl Linnaeus in 1773. Many non-Australian species tend to be thorny, whereas the majority of Australian acacias are not. They are pod-bearing, with sap and leave typically bearing large amounts of tannins and condensed tannins that historically in many species found use as pharmaceuticals and preservatives. AC, a deciduous thorn like tree mainly found in India and also found in deciduous forests around the world. The leaves, bark, heartwood has many nutritional and medicinal uses. The extract of Acacia catechu have been reported to have various pharmacological effects like immuno modulatory2 , anti pyretic, hypoglycaemic3 , anti diarrhoeal4, hepatoprotective activity4,5. Heartwood is used to yield concentrated aqueous extract i.e. cutch. Cutch (extract) is astringent, cooling, and digestive. It is useful in cold and cough6,7,8,9 ulcers, boils and eruptions of the skin, bleeding piles, uterine haemorrhages,atonic dyspepsia, chronic bronchitis etc. An antibacterial mouthwash made from the extract treats gingivitis and mouth sores.
is commercially used to obtain Katha (a concentrated filtered extract) in North India. It is found widely distributed in Jammu, Punjab, Himachal Pradesh, Uttar Pradesh, Madhya Pradesh, Bihar, Andra Pradesh and Orissa. Catechuoides is found in terrain region of Sikkim, Assam and West Bengal, whereas Sundra, generally known as Lal Khair (red catechu) is found in Deccan, Gujrat, Rajasthan and southern Maharashtra .The tree can be propagated by planting its seeds, which are soaked in hot water first. After about six months in a nursery, the seedlings can be planted in the field.
Climate: In the natural habitat of khair, the absolute maximum shade temperature varies from 40oC to 50oC and the absolute minimum from 2.5oC to 7.5oC. The mean daily maximum temperature in May which is generally the hottest month in the hot weather varies from 37.5oC to 43.5oC. The mean daily minimum temperature in January which is the coldest month of the year varies from 1.0oC to 2.1oC.Acacia catechu is essentially a tree of comparatively dry regions though in its alluvial form, it extends into regions of heavy rainfall as in the Eastern subHimalayan tract, where it is found in places with rainfall as high as 3,800 mm. Away from riverain tracts it occurs in localities where the normal rainfall varies from 500 to 2160 mm. Khair develops to its maximum size in localities with heavy rainfall but it is decidedly xerophilous and grows in dry situations where few other species survive.
Botanical description: (11) AC is a moderate sized tree, not reaching more than 9-12 meters high and often smaller, with a short, somewhat crooked trunk.. The bark is dark grey and rough. The leaves numerous, alternate, stalked, often armed with a few prickles, bipinnately compound, leaflets 30-50 pairs. The rachis branching from the mid-rib has 4 to 5 round prickles. The rachis is nearly 10 to 20 cm long and bears 20 to 60 pinnae each about 3 to 4 cm long. The flowering occurs in May and June. Its inflorescence is pale yellow to cream colored .The foliage is softly textured; light green and oval-shaped. The branches are thin and spike like because tiny thorns grow around the exterior. The fruit, pod, 5-12 cm long, brown, acute, shining, with 3-10 seeds.AC typically reaches heights of up to 50 feet .The sap wood of AC is large and yellowish white and heart wood is small and red in colour
CHEMICAL CONSTITUENTS
Main chemical constituents of Acacia catechu Willd are catechin, (-) epicatechin, epigallocatechin, epicatechin gallate, epigallocatechin gallete rocatechin, phloroglucin, protocatechuic acid, quercetin, poriferasterol glucosides, poriferasterol, acyglucosides, lupenone, lupeol, procyanidin AC, kaempferol, dihydrokaemferol , L?arabinose, D?galactose, D?rhamnose andaldobiuronic acid 27, afzelchin gum and mineral (15 ,16-22) Another important constituent is taxifolin .Catechin is biologically highly active. It is used as a haemostatic. Taxifolin has antibacterial23, anti-fungal24, antiviral, antiinflammatory, and antioxidant activity25,26 . The medicinal properties of Acacia catechu is due to the antioxidant properties of these constituents.
Phytochemical Analysis Preliminary phytochemical screening of the leaves extracts of AC was performed as per standard procedure (28, 29) which revealed that the presence of carbohydrates, steroids, alkaloids, glycosides, tannins, saponins, flavones, and phenolic compounds.
ETHNOPHARMACOLOGY Acacia Catechu is an herb. The leaves, shoots, and wood are used to make medicine. The two types of catechu, black catechu and pale catechu, contain slightly different chemicals, but they are used for the same purposes and at the same dose. Catechu is used for diarrhea, swelling of the nose and throat, dysentery, swelling of the colon (colitis), bleeding, indigestion, osteoarthritis, and cancer. People apply catechu directly to the skin for skin diseases, hemorrhoids, and traumatic injuries; to stop bleeding; and for dressing wounds. Catechu is included in mouthwashes and gargles used for gum disease (gingivitis), pain and swelling inside the mouth (stomatitis), sore throat, and mouth ulcers, hoarseness of voice. Cyanidanol, an active principle of Acacia catechu, is claimed to be effective in treating liver diseases.[30]In foods and beverages, catechu is used as a flavoring agent. It is used in the diseases like worms, wounds, fever, edema, pruritis, diabetes, obesity, blood disorders, cough, asthma and anemia etc. The bark, wood extracts, fruits, Gum and flowering tops of AC are used for medicinal purpose. The plant is useful, internally as well as externally. It possess anti-helmentic anti dysenteric and antipyretic and hypotensive (31) properties. It is also used in melancholia, conjunctivitis, haemoptysis, chest pain, asthma, colicky pain, gravel, bronchitis etc.32, it was reported that both t he natural dyes 33 and bark 34 and whole plant 35has microbicidal activity.
PHARMACOLOGICAL ACTIVITIES: Anti microbial Activity: 24,36 Study showed Acacia catechu Willd leaves Extract is found to possess broad-spectrum antimicrobial activity Results showed AC has antimicrobial activity by inhibiting common human pathogenic organisms like Staphylococcus aureus (Gram positive), Escherichiacoli, Pseudomonas aeruginosa, Klebsiella pneumoniae, and Salmonellatyphi (Gram negative) and fungi like Candida albicans, Aspergillus niger supporting its use in traditional medicine. Acacia catechu Willd leaves, Bark, root extract also possess Anti mycotic activity . The bark extract showed an inhibitory effect on the growth of fungi such as Piricularia oryzae and Colletotrichum falcatum.
AntiOxidant Activity:25,37 Study of 70% methanol extract of heartwood extract of Acacia catechu showed significant antioxidant activity , iron chelating and DNA protective activity which is partly due to the phenolic and flavonoid compounds present in it Standard methods like The dot?blot assay, TLC study and the DPPH assay showed that the AC extract is a highly effective antioxidant. Catechin, rutin and isorhamnetin are reported as free radical scavengers and these compounds largely contribute to the bio?potency of Acacia catechu.
Antidiarrheal activity: 4,38 Antidiarrhoeal activity was evaluated in albino rats after inducing diarrhea with castor oil.1 The antidiarrhoeal property of the ethyl acetate extract of Acacia catechu appears to be due to its tannin[38] content, which has astringent property.
Antipyretic activity: (39-41) The antipyretic effect of Acaciacatechu is due to presence of flavonoid compounds, as some flavonoids are predominant inhibitors of cyclooxygenase or lipooxygenase.[39], [40],[41]
Hypoglycaemic activity: (42-46) Acacia catechu possess hypoglycaemic activity. The hypoglycaemic effect of A. catechu may be due to presence of flavonoids which acts as insulin secretagogues.[42] Epicatechin, a flavonoid compound, is reported to promote regeneration of β cells of the Islets of Langerhans . [43],[44],[45],[46)
Hepatoprotective activity: 30,46,47 Acacia Catechu also possesses hepatoprotective property found in the heartwood. During trials, an ethyl acetate extract in male rats decreased CCI4-induced elevated enzyme levels in acute and chronic models of liver damage. The results indicated some form of repair of the structural integrity of the hepatocyte cell membrane or regeneration of damaged liver cells. Decreased levels of serum bilirubin after treatment with the extract in both acute and chronic liver damage indicated the efficacy of the extract in restoring normal functional status of the liver and the protective action of the extract was further substantiated by histopathological observations The hepatoprotective activity of A. catechu could be due to the presence of bioflavonoids which have hepatoprotective and antioxidant properties.[30],[46],[47]
Immuno modulatory activity: (48-53) Study on Wistar albino rats shows that the aqueous extract of Acacia catechu have significant effect on both the cell mediated and the humoral immunity The exact constituent(s)responsible for the immunomodulatory effect is not known. However, the catechins, by virtue of their antimicrobial (48, 49), antiinflammatory (50), antiviral (51, 52)and antioxidant (53) effect may be the main constituents responsible for their activity.
Anti inflammatory activity:(54-57) Study shows 57 extract containing both baicalin and (_)-catechin directly inhibits the production Of inflammatory fatty acids by acting on the COX and LOX enzymes. Since elevated AA metabolism is part of the etiology of arthritis, 54,55 inhibition of the production of these inflammatory mediators via dual inhibition of the COX and LOX pathways may provide a way to manage OA safely while providing acceptable efficacy. Toxicological safety studies in animals and humans have shown the combination of S. baicalensis and A. catechu extracts to be safe.56
CONCLUSION
In the present review we have made an attempt to explore and provide the maximum information of botanical, pharmacognostical with history and cultivation, Ethnopharmacological, phytochemical, nutritional, pharmacological information on Acacia catechu willd, a medicinal herb used in the Indian system of medicine. Various chemical constituent present in this plant are catechin and catechutannic acid. epicatechin, Atzelchin, catechin tetramer, dicatechin, gallochin, gossypetin, phlobatannin, kaempferol, quercitrin, quercitin ,taxifolin found to possess diverse pharmacological activities. This data provides that. Acacia catechu willd as a potential medicinal herb.
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